Application 214628
- Type
- NDA
- Sponsor
- NEVAKAR INJECTABLES, INC.
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION | NOREPINEPHRINE IN SODIUM CHLORIDE | INJECTABLE;INJECTION | EQ 250ML BASE/ | No | No |
| 002 | NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION | NOREPINEPHRINE IN SODIUM CHLORIDE | INJECTABLE;INJECTION | EQ 8MG BASE/250ML | No | No |
| 003 | NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION | NOREPINEPHRINE IN SODIUM CHLORIDE | INJECTABLE;INJECTION | EQ 16MG BASE/250ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | |
| N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | |
| N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N214628-001 | 10159657 | 2038-01-30 | Drug product | 2022-11-02 | |
| N214628-001 | 10226436 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 |
| N214628-001 | 10420735 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 |
| N214628-001 | 10568850 | 2038-01-30 | Drug product | 2022-11-02 | |
| N214628-001 | 11413259 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 |
| N214628-001 | 11602508 | 2038-01-30 | Drug product | 2023-03-14 | |
| N214628-001 | 12245996 | 2038-01-30 | Drug product | 2025-03-26 | |
| N214628-002 | 10159657 | 2038-01-30 | Drug product | 2022-11-02 | |
| N214628-002 | 10226436 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 |
| N214628-002 | 10420735 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 |
| N214628-002 | 10568850 | 2038-01-30 | Drug product | 2022-11-02 | |
| N214628-002 | 11413259 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 |
| N214628-002 | 11602508 | 2038-01-30 | Drug product | 2023-03-14 | |
| N214628-002 | 12245996 | 2038-01-30 | Drug product | 2025-03-26 | |
| N214628-003 | 10159657 | 2038-01-30 | Drug product | 2022-11-02 | |
| N214628-003 | 10226436 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 |
| N214628-003 | 10420735 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 |
| N214628-003 | 10568850 | 2038-01-30 | Drug product | 2022-11-02 | |
| N214628-003 | 11413259 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 |
| N214628-003 | 11602508 | 2038-01-30 | Drug product | 2023-03-14 | |
| N214628-003 | 12245996 | 2038-01-30 | Drug product | 2025-03-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214628-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214628-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N214628-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-10-06 | 8072bd15b7f6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N214628-001 | 10159657 | 2038-01-30 | Drug product | 2022-11-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-001 | 10226436 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-001 | 10420735 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-001 | 10568850 | 2038-01-30 | Drug product | 2022-11-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-001 | 11413259 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-001 | 11602508 | 2038-01-30 | Drug product | 2023-03-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-001 | 12245996 | 2038-01-30 | Drug product | 2025-03-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-002 | 10159657 | 2038-01-30 | Drug product | 2022-11-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-002 | 10226436 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-002 | 10420735 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-002 | 10568850 | 2038-01-30 | Drug product | 2022-11-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-002 | 11413259 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-002 | 11602508 | 2038-01-30 | Drug product | 2023-03-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-002 | 12245996 | 2038-01-30 | Drug product | 2025-03-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-003 | 10159657 | 2038-01-30 | Drug product | 2022-11-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-003 | 10226436 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-003 | 10420735 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-003 | 10568850 | 2038-01-30 | Drug product | 2022-11-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-003 | 11413259 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-003 | 11602508 | 2038-01-30 | Drug product | 2023-03-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214628-003 | 12245996 | 2038-01-30 | Drug product | 2025-03-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-001 | 10159657 | 2038-01-30 | Drug product | 2022-11-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-001 | 10226436 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-001 | 10420735 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-001 | 10568850 | 2038-01-30 | Drug product | 2022-11-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-001 | 11413259 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-001 | 11602508 | 2038-01-30 | Drug product | 2023-03-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-001 | 12245996 | 2038-01-30 | Drug product | 2025-03-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-002 | 10159657 | 2038-01-30 | Drug product | 2022-11-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-002 | 10226436 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-002 | 10420735 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-002 | 10568850 | 2038-01-30 | Drug product | 2022-11-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-002 | 11413259 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-002 | 11602508 | 2038-01-30 | Drug product | 2023-03-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-002 | 12245996 | 2038-01-30 | Drug product | 2025-03-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-003 | 10159657 | 2038-01-30 | Drug product | 2022-11-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-003 | 10226436 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-003 | 10420735 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-003 | 10568850 | 2038-01-30 | Drug product | 2022-11-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214628-003 | 11413259 | 2038-01-30 | U-3461 | Drug product | 2022-11-02 | 31067a03dcf5… |
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 |
|---|---|---|---|---|---|---|
| Norepinephrine | NOREPINEPHRINE BITARTRATE | Long Grove Pharmaceuticals, LLC | 759807dd-61a8-4f6f-8bf5-f6ee773c81bc | 2025-12-04 | Warnings, Adverse reactions | 214628 NDA214628 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42023-245 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE IN SODIUM CHLORIDE | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-246 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE in Sodium Chloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-247 | NOREPINEPHRINE BITARTRATE | Norepinephrine in Sodium Chloride | Par Pharmaceutical, Inc. | NDA | Current |