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HYDROCHLORIDE | SYRUP;ORAL | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | SYRUP;ORAL | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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PLAIN | PROMETHAZINE HYDROCHLORIDE | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | ||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PLAIN | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 |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| PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | c2088c7a36db… | ||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| PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | c2088c7a36db… | |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 |
|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | bae9c9c1-107f-0fcb-e053-2a95a90a75b2 | 2026-09-09 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Redpharm Drug | 5a797d11-19b0-fd33-e063-6394a90a4d58 | 2026-09-02 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 974208c8-4aad-4fb9-991b-cf3085034272 | 2026-08-24 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | 5991de26-891a-153a-e063-6294a90a4633 | 2026-08-19 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 5590f356-0904-58f6-e063-6294a90a6ad5 | 2026-08-18 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 6bcaa89f-5f14-dc45-e053-2a91aa0aac54 | 2026-07-30 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Coupler LLC | 55f618d1-4466-3200-e063-6394a90a89a8 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 9e4e57fa-4ce3-4b7b-be5a-381801ed0386 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Sportpharm LLC | 4156e780-7ecf-bcae-e063-6394a90a2ae2 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | ASCLEMED USA INC. | 4d30e587-6d59-4cf5-ab45-c7639f759df9 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 804e2525-d61f-7bed-e053-2991aa0a5daa | 2026-06-30 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488 | 2026-06-05 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47 | 2026-06-04 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8 | 2026-05-22 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f93ca67d-362a-473f-8296-2952da77c074 | 2026-05-22 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d | 2026-05-22 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Atlantic Biologicals Corp. | 4f99bbd5-02f7-2fed-e063-6394a90a6355 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | bf951b5b-6e38-44a9-895e-0d60c6b9d343 | 2026-03-27 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 81fd29a9-c090-49ba-8b48-bd3656ca0c92 | 2026-03-19 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | KVK-Tech, Inc. | 7a137adf-39b7-4b14-80da-c3cac9ad562a | 2026-03-13 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.