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HYDROCHLORIDE | SYRUP;ORAL | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | SYRUP;ORAL | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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PLAIN | PROMETHAZINE HYDROCHLORIDE | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | ||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PLAIN | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 |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| PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | c2088c7a36db… | ||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| PROMETHAZINE HYDROCHLORIDE PLAIN | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1984-04-18 | c2088c7a36db… | |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 | Henry Schein, Inc. | 7fa840ad-10e7-4faf-9325-451648604161 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | REMEDYREPACK INC. | adb04635-584f-4fef-98ca-2574be312a73 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Chartwell RX, LLC | 2ca17cd4-460e-4d54-8c53-a58a2b80e5cb | 2026-01-30 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | 7ce351d8-47be-4937-aad2-153208c93b53 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | f6ca1097-1c75-c682-e053-6294a90a2bd6 | 2026-01-01 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | d9cb1a44-d646-d9e9-e053-2995a90a24ff | 2026-01-01 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | 075f052e-7f38-7f75-e063-6394a90a512b | 2026-01-01 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | ba4ec2d8-1da4-473b-9ef8-57051cb2c0f7 | 2025-12-26 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 0b5734b8-6a52-44ff-ac29-9a91a4335394 | 2025-12-20 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | ProPharma Distribution | 38673af1-112e-9ddd-e063-6294a90af465 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| promethazine hydrochloride | PROMETHAZINE HYDROCHLORIDE | Cranbury Pharmaceuticals, LLC | d32ea9db-11d4-400d-b7ef-dd0ec01b796d | 2025-12-12 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | ProPharma Distribution | 45b09a50-dab2-e83d-e063-6394a90aa813 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| promethazine hydrochloride | PROMETHAZINE HYDROCHLORIDE | ATLANTIC BIOLOGICALS CORP | 69934bbb-922c-4752-b253-f2f07340de8d | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 46b869e2-9305-43ae-bb15-919a6d09b6ff | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Chartwell Governmental & Specialty RX, LLC. | e5d2156d-1f66-4fdf-a3ae-5e1325218c8b | 2025-11-21 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | American Health Packaging | a8fe4bc5-961b-4441-b8e2-ef93e4e137b6 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | American Health Packaging | 57b4bf23-c563-4357-9dcf-066cbc1280e4 | 2025-11-13 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | d7675718-0a57-41ff-a771-79afc12150aa | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | c525cb2c-9a01-4a9b-ad2c-08630719953d | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | e16238dc-9292-49ac-b80f-8afeccb88bc5 | 2025-10-24 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.