- Product NDC
- 0264-9341
- 11-digit product format
- 002649341
- Labeler code
- 0264
- Product ID
- 0264-9341_60e4949d-e697-445e-a69a-d186bc7c136e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- B. Braun Medical Inc.
- Application
- NDA019018
- Marketing category
- NDA
- Marketing start
- 1984-07-20
- Marketing end
- 0000-00-00
- Substance
- ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; CYSTEINE HYDROCHLORIDE; HISTIDINE; TYROSINE; ACETYL L-TYROSINE; ALANINE; ARGININE; PROLINE; SERINE; GLYCINE; ASPARTIC ACID; GLUTAMIC ACID; TAURINE
- Active strength
- 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
- Pharmacologic classes
- Amino Acid [EPC],Amino Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table| 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 | 0264-9341-55 | 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 | 0264-9341-55 | 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 | 0264-9341-55 | 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 | 0264-9341-55 | 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 | 0264-9341-55 | 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 | 0264-9341-55 | 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 | 0264-9341-55 | 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 | 0264-9341-55 | 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 | 0264-9341-55 | 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 | 0264-9341-55 | 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 | 0264-9341-55 | 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 | 0264-9341-55 | 557ba5c1ecfa… | 9c80585c8c6e… |
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.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|
| 2026-08-18 06:07:40 | 2026-07 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N019018-001 | TROPHAMINE | 6% (6GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1984-07-20 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N019018-003 | TROPHAMINE 10% | 10% (10GM/100ML) | INJECTABLE / INJECTION | | RLD, RS | 1988-09-07 | bb7c543d1eb4… |