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#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0338-1136 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 0338-1136 | 0338-1136-03 | D | Discontinued by firm | 2026-09-14 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0338-1136-03 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0338-1136-03 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0338-1136-03 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0338-1136-03 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0338-1136-03 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0338-1136-03 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0338-1136-03 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0338-1136-03 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0338-1136-03 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0338-1136-03 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0338-1136-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0338-1136-03 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020734-001 | CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | 2.75%;5GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020734-002 | CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | 2.75%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020734-005 | CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | 2.75%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020734-007 | CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | 4.25%;5GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020734-008 | CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | 4.25%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020734-010 | CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER | 4.25%;20GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020734-011 | CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | 4.25%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020734-014 | CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | 5%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020734-015 | CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER | 5%;15GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020734-016 | CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER | 5%;20GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020734-017 | CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | 5%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020734-018 | CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER | 5%;35GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020734-019 | CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER | 8%;14GM/100ML | INJECTABLE / INJECTION | 2021-04-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-001 | CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | 2.75%;5GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-002 | CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | 2.75%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-005 | CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | 2.75%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-007 | CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | 4.25%;5GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-008 | CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | 4.25%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-010 | CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER | 4.25%;20GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-011 | CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | 4.25%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-014 | CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | 5%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-015 | CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER | 5%;15GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-016 | CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER | 5%;20GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-017 | CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | 5%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-018 | CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER | 5%;35GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020734-019 | CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER | 8%;14GM/100ML | INJECTABLE / INJECTION | 2021-04-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-001 | CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | 2.75%;5GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-002 | CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | 2.75%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-005 | CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | 2.75%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-007 | CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | 4.25%;5GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-008 | CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | 4.25%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-010 | CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER | 4.25%;20GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-011 | CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | 4.25%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-014 | CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | 5%;10GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-015 | CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER | 5%;15GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-016 | CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER | 5%;20GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-017 | CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | 5%;25GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-018 | CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER | 5%;35GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020734-019 | CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER | 8%;14GM/100ML | INJECTABLE / INJECTION | 2021-04-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020734-001 | CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | 2.75%;5GM/100ML | INJECTABLE / INJECTION | 1997-09-29 | 31067a03dcf5… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 |