Application 008381
- Type
- NDA
- Sponsor
- ANI PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 003 | PROMETHAZINE HYDROCHLORIDE PLAIN | PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | PROMETHAZINE HYDROCHLORIDE PLAIN | PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | PROMETHAZINE HYDROCHLORIDE | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | ||
| N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML | SYRUP / ORAL | RLD | 1984-04-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N008381-003 | PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N008381-004 | PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML | SYRUP / ORAL | RLD | 1984-04-18 | 4b0b4de00fa7… |
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 |
|---|---|---|---|---|---|---|
| PROMETHEGAN | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97 | 2025-10-20 | Boxed warning, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7d766cf7-a21c-4eaf-bbdc-00f2939ef19a | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Major Pharmaceuticals | 4cee8622-7d59-4794-8e32-54f7aac1d923 | 2025-09-22 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | BluePoint Laboratories | 44cd6d46-fbb9-4836-9426-d8ce2cb6d66d | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 7a186bcd-ab8c-4695-8289-4cd33bb551cf | 2025-08-05 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 13d9e59d-eadb-41d5-9f47-9c11a6efb31c | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | d545105f-27dc-4820-b0b1-fcf17e0be0f0 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PHENERGAN | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 6f7e47cc-f823-4336-8107-f980e3049617 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Asclemed USA, Inc. | 1b1cee64-c0b5-4da6-92d0-1769350a5181 | 2025-06-07 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Xttrium Laboratories, Inc. | 302bfea2-d403-d315-e063-6294a90a37dd | 2025-04-07 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Kesin Pharma Corporation | 28793bd2-bd40-4571-e063-6394a90ae789 | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 74834e1b-0d90-0542-e053-2991aa0aa1ef | 2025-02-10 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Coupler LLC | 2d996287-9eed-265a-e063-6294a90a6969 | 2025-02-07 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 12400c65-f93b-47a5-8167-1fb14337130b | 2025-01-07 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f4c23037-e415-7604-e053-2995a90a5bb6 | 2024-12-31 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Zydus Lifesciences Limited | 4eaa8291-9cde-4205-857b-925ea8d618ba | 2024-12-04 | PROMETHAZINE HYDROCHLORIDE | |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 05907a49-537f-4bf2-8a5f-5e905f19fece | 2024-10-30 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 6aa6bfcc-024b-4ee2-a586-6c4ca879cea4 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 69eea039-0098-4e2f-a832-152583b16f05 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | b7137912-d119-4899-9c93-09c1c625f290 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.