NDC codes

FDA NDC Directory
Product NDC (as listed)0338-1147Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00338-1147Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0338-1147-03003381147031000 mL in 1 BAG (0338-1147-03)Marketed from Mar 26, 1997

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Clinimix E
Generic name (nonproprietary)
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose
Active ingredients
Leucine — 365 mg/100mLPhenylalanine — 280 mg/100mLLysine — 290 mg/100mLMethionine — 200 mg/100mLIsoleucine — 300 mg/100mLValine — 290 mg/100mLHistidine — 240 mg/100mLThreonine — 210 mg/100mLTryptophan — 90 mg/100mLAlanine — 1035 mg/100mLGlycine — 515 mg/100mLArginine — 575 mg/100mLProline — 340 mg/100mLSerine — 250 mg/100mLTyrosine — 20 mg/100mLSodium acetate — 340 mg/100mLPotassium phosphate, Dibasic — 261 mg/100mLMagnesium chloride — 51 mg/100mLSodium chloride — 59 mg/100mLCalcium chloride — 33 mg/100mLDextrose — 15 g/100mL
Dosage form
Injection
Route
Intravenous
Labeler
Baxter Healthcare CompanyNDC labeler code 0338
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020678
Marketing start
Listing expires
Other FDA classes
Amino Acids (Chemical structure)Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Phosphate Chelating Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers
Product ID 0338-1147_c5f1da6b-9b01-4814-97a5-3d7efbedec9cSPL ID c5f1da6b-9b01-4814-97a5-3d7efbedec9cSPL set ID 8469d6fb-d6ef-476f-8cc3-0905192de0a8RxCUI 800998, 801000, 801010, 801012, 801019, 801021, 801029, 801031, 1090635, 1090639UNII 02F3473H9O, TE7660XO1C, M4I0D6VV5M, GMW67QNF9C, 9DLQ4CIU6V, 94ZLA3W45F, 4550K0SC9B, IY9XDZ35W2, OF5P57N2ZX, HG18B9YRS7, 452VLY9402, 04Y7590D77, CI71S98N1Z, AE28F7PNPL, 8DUH1N11BX, 47E5O17Y3R, 4QD397987E, K3Z4F929H6, 42HK56048U, 451W47IQ8X, 2ZD004190S
Pharmacologic class
Amino Acid; Blood Coagulation Factor; Calculi Dissolution Agent; Osmotic Laxative; Phosphate Binder

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400338114703 followed by a unit qualifier and the quantity

Package 00338-1147-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients. CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0338-1147

What is NDC 0338-1147?
0338-1147 is the product NDC for Clinimix E, Leucine 365 mg/100mL + 20 more ingredients injection, listed with the FDA by Baxter Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clinimix E (Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose).
What is the active ingredient?
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium acetate, Potassium phosphate, Dibasic, Magnesium chloride, Sodium chloride, Calcium chloride, Dextrose.
Who is the labeler?
Baxter Healthcare Company, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clinimix E?
21 other product NDCs are listed under this name. See all Clinimix E NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Clinimix E NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 201 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-702000338-7020-06
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 311 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-702200338-7022-06
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 311 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-702400338-7024-04
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 311 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-702600338-7026-06
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 311 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-702800338-7028-04
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 365 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-703000338-7030-06
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 365 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-703200338-7032-04
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 365 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-703400338-7034-06
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 365 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-703600338-7036-04
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 584 mg/100mL + 19 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-020200338-0202-06

All 22 Clinimix E NDCs

Other NDCs under NDA 020678

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 020678
ProductStrengthForm · routeLabelerProduct NDC
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 584 mg/100mL + 19 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-0202
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 584 mg/100mL + 19 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-0206
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 584 mg/100mL + 19 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-0210
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 584 mg/100mL + 19 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-0214
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 311 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-1113
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 311 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-1115
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 365 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-1123
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 365 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-1125
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 201 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-1142
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 311 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-1144
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 311 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-1145
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 365 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-1148
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 201 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-7020
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 311 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-7022
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 311 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-7024
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 311 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-7026
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 311 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-7028
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 365 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-7030
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 365 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-7032
Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseLeucine 365 mg/100mL + 20 more ingredientsInjectionIntravenousBaxter Healthcare Company0338-7034

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