Application 040596
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | No | No |
| 002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040596-001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | |
| A040596-002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | |
| A040596-003 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040596-001 | AB |
| A040596-002 | AB |
| A040596-003 | AB |
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 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040596-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040596-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040596-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040596-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040596-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040596-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040596-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040596-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040596-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040596-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040596-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040596-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040596-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040596-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040596-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040596-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040596-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040596-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040596-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040596-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040596-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040596-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040596-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040596-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040596-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040596-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040596-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040596-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040596-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040596-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040596-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040596-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040596-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040596-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040596-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040596-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040596-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040596-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040596-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040596-001 | AB | 1 | 8072bd15b7f6… |
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 | Coupler LLC | 55f618d1-4466-3200-e063-6394a90a89a8 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 9e4e57fa-4ce3-4b7b-be5a-381801ed0386 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Sportpharm LLC | 4156e780-7ecf-bcae-e063-6394a90a2ae2 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | ASCLEMED USA INC. | 4d30e587-6d59-4cf5-ab45-c7639f759df9 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 5590f356-0904-58f6-e063-6294a90a6ad5 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | bae9c9c1-107f-0fcb-e053-2a95a90a75b2 | 2026-03-05 | Warnings, Adverse reactions | 040596 ANDA040596 72189-176 |
| Phenergan | PROMETHAZINE HCL | Direct_Rx | eec705f7-123a-7926-e053-2a95a90af46d | 2026-03-05 | Warnings, Adverse reactions | 040596 ANDA040596 72189-402 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | REMEDYREPACK INC. | adb04635-584f-4fef-98ca-2574be312a73 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 70518-2488 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | American Health Packaging | a8fe4bc5-961b-4441-b8e2-ef93e4e137b6 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | American Health Packaging | 57b4bf23-c563-4357-9dcf-066cbc1280e4 | 2025-11-13 | Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 6728bb41-5d50-4abb-bb73-993dcc16ee66 | 2025-10-03 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 974208c8-4aad-4fb9-991b-cf3085034272 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | BluePoint Laboratories | 44cd6d46-fbb9-4836-9426-d8ce2cb6d66d | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Coupler LLC | 2d996287-9eed-265a-e063-6294a90a6969 | 2025-02-07 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f4c23037-e415-7604-e053-2995a90a5bb6 | 2024-12-31 | Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Zydus Lifesciences Limited | 4eaa8291-9cde-4205-857b-925ea8d618ba | 2024-12-04 | 040596 ANDA040596 | |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 6aa6bfcc-024b-4ee2-a586-6c4ca879cea4 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 69eea039-0098-4e2f-a832-152583b16f05 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | b7137912-d119-4899-9c93-09c1c625f290 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 84899861-8fed-536d-e053-2991aa0a42b2 | 2024-09-26 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70518-2488 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-353 | Promethazine Hydrochloride | Promethazine Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-353 | Promethazine Hydrochloride | Promethazine Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-658 | Promethazine Hydrochloride | Promethazine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-658 | Promethazine Hydrochloride | Promethazine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-1139 | Promethazine Hydrochloride | Promethazine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1139 | Promethazine Hydrochloride | Promethazine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72189-176 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 72189-176 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 72189-176 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 72189-402 | Phenergan | Promethazine HCL | Direct_Rx | ANDA | Current |