Prescription drug · NDA
Clinimix NDC 0338-1099
Leucine 365 mg/100mL + 15 more ingredients · Injection · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-1099-04 | 00338109904 | 2000 mL in 1 BAG (0338-1099-04)Marketed from Sep 29, 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
- Generic name (nonproprietary)
- leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, 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/100mLDextrose — 15 g/100mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020734
- Marketing start
- Listing expires
- Other FDA classes
- Amino Acids (Chemical structure)
- Identifiers
- Product ID 0338-1099_ff41ef10-43c8-4813-9b53-f7f2b9dbb468SPL ID ff41ef10-43c8-4813-9b53-f7f2b9dbb468SPL set ID dccff103-8695-400c-a15d-cc2fd078760aRxCUI 800401, 800405, 800416, 800420, 800434, 800438, 800440, 800444UNII 9DLQ4CIU6V, 8DUH1N11BX, 47E5O17Y3R, OF5P57N2ZX, HG18B9YRS7, TE7660XO1C, 94ZLA3W45F, 4QD397987E, K3Z4F929H6, 42HK56048U, 452VLY9402, 04Y7590D77, GMW67QNF9C, IY9XDZ35W2, AE28F7PNPL, 2ZD004190S
- Pharmacologic class
- Amino Acid
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.
- NDC on a medical claim
N400338109904followed by a unit qualifier and the quantityPackage 00338-1099-04. 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 .
Indications (excerpt from the label)
CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0338-1099
- What is NDC 0338-1099?
- 0338-1099 is the product NDC for Clinimix, Leucine 365 mg/100mL + 15 more ingredients injection, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clinimix (Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose).
- What is the active ingredient?
- Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose.
- Who is the labeler?
- Baxter Healthcare Corporation, 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?
- 20 other product NDCs are listed under this name. See all Clinimix NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clinimix products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7001 | 00338-7001-06 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7003 | 00338-7003-04 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7005 | 00338-7005-06 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7007 | 00338-7007-04 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 365 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7009 | 00338-7009-06 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 365 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7011 | 00338-7011-04 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 365 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7013 | 00338-7013-06 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 365 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7015 | 00338-7015-04 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1134 | 00338-1134-03 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1089 | 00338-1089-04 |
Other NDCs under NDA 020734
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1089 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1091 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 365 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1101 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 584 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-0180 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7001 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1133 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7003 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 584 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-0184 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7005 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1134 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 584 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-0188 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 311 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7007 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 365 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1137 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 365 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7009 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 365 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1138 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 365 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7011 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 365 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7013 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 584 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-0194 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 365 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-7015 |
| Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose | Leucine 438 mg/100mL + 15 more ingredients | InjectionIntravenous | Baxter Healthcare Corporation | 0338-0198 |