CLINIMIX
- Product NDC
- 0338-1136
- 11-digit product format
- 003381136
- Labeler code
- 0338
- Product ID
- 0338-1136_97fd7bf4-8d2c-43d8-968b-7ba3c0554711
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- NDA020734
- Marketing category
- NDA
- Marketing start
- 1997-09-29
- Marketing end
- 2020-02-29
- Substance
- LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE
- Active strength
- 311 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL
- Pharmacologic classes
- Amino Acid [EPC],Amino Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0338-1136 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0338-1136 | 0338-1136-03 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020734-001 | CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 2.75%;5GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | ||
| N020734-002 | CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 2.75%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | ||
| N020734-005 | CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 2.75%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | ||
| N020734-007 | CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;5GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | ||
| N020734-008 | CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | ||
| N020734-010 | CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;20GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | ||
| N020734-011 | CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | ||
| N020734-014 | CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 5%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | ||
| N020734-015 | CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 5%;15GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | ||
| N020734-016 | CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 5%;20GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | ||
| N020734-017 | CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 5%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | ||
| N020734-018 | CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 5%;35GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | ||
| N020734-019 | CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 8%;14GM/100ML | INJECTABLE / INJECTION | 2021-04-13 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N020734-001 | CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | 2.75%;5GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N020734-002 | CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | 2.75%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N020734-005 | CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | 2.75%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N020734-007 | CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | 4.25%;5GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N020734-008 | CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | 4.25%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N020734-010 | CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER | 4.25%;20GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N020734-011 | CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | 4.25%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N020734-014 | CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | 5%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N020734-015 | CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER | 5%;15GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N020734-016 | CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER | 5%;20GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N020734-017 | CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | 5%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N020734-018 | CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER | 5%;35GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N020734-019 | CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER | 8%;14GM/100ML | INJECTABLE / INJECTION | 2021-04-13 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CLINIMIX | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSE | Baxter Healthcare Corporation | dccff103-8695-400c-a15d-cc2fd078760a | 2021-04-13 | Warnings, Adverse reactions | 020734 NDA020734 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-1136-03 | ML - Milliliter | 0338-1136 | 7d6aa445-cb88-453c-b585-d81b3c231cfb | 1 | 2012-07-24 |