Clinimix E NDC 0338-1125

NDC codes

FDA NDC Directory

Product NDC (as listed)0338-1125Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00338-1125Add 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 NDC	11-digit (billing)	Package	Copy
0338-1125-04	00338112504	2000 mL in 1 BAG (0338-1125-04)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 — 20 g/100mL
Dosage form: Injection
Route: Intravenous
Labeler: Baxter Healthcare Company
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020678
Marketing start: Mar 26, 1997
Listing expires: Dec 31, 2027
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 0338-1125_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 8DUH1N11BX, 94ZLA3W45F, GMW67QNF9C, CI71S98N1Z, OF5P57N2ZX, 04Y7590D77, HG18B9YRS7, 451W47IQ8X, 2ZD004190S, 4QD397987E, 47E5O17Y3R, TE7660XO1C, 02F3473H9O, K3Z4F929H6, 4550K0SC9B, IY9XDZ35W2, 42HK56048U, M4I0D6VV5M, 452VLY9402, AE28F7PNPL, 9DLQ4CIU6V
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

N400338112504 followed by a unit qualifier and the quantity

Package 00338-1125-04. 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 Apr 13, 2021.

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)