Promethazine Hydrochloride
- Product NDC
- 60760-830
- Requested package NDC
- 60760-830-20
- 11-digit product format
- 607600830
- Labeler code
- 60760
- Product ID
- 60760-830_7acbf230-ed2f-3fcc-e053-2a91aa0aa020
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- St. Mary's Medical Park Pharmacy
- Application
- ANDA091179
- Marketing category
- ANDA
- Marketing start
- 2012-12-19
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 60760-830 | 60760-830-20 | D | Discontinued by firm | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091179-001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | |
| A091179-002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | |
| A091179-003 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091179-001 | AB |
| A091179-002 | AB |
| A091179-003 | 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 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 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 | A091179-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091179-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091179-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091179-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091179-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091179-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091179-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091179-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091179-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091179-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091179-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091179-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091179-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091179-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091179-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091179-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091179-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091179-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091179-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091179-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091179-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091179-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091179-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091179-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091179-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091179-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091179-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091179-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091179-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091179-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091179-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091179-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091179-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091179-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091179-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091179-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091179-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091179-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091179-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091179-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-830-20 | EA - Each | 60760-830 | 86a08ce3-abc4-4a07-903d-23f8fa84e864 | 1 | 2018-01-12 |
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 | A-S Medication Solutions | bf951b5b-6e38-44a9-895e-0d60c6b9d343 | 2026-03-27 | Warnings, Adverse reactions | 091179 ANDA091179 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 81fd29a9-c090-49ba-8b48-bd3656ca0c92 | 2026-03-19 | Warnings, Adverse reactions | 091179 ANDA091179 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | 075f052e-7f38-7f75-e063-6394a90a512b | 2026-01-01 | Warnings, Adverse reactions | 091179 ANDA091179 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | ba4ec2d8-1da4-473b-9ef8-57051cb2c0f7 | 2025-12-26 | Warnings, Adverse reactions | 091179 ANDA091179 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 0b5734b8-6a52-44ff-ac29-9a91a4335394 | 2025-12-20 | Warnings, Adverse reactions | 091179 ANDA091179 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | e16238dc-9292-49ac-b80f-8afeccb88bc5 | 2025-10-24 | Warnings, Adverse reactions | 091179 ANDA091179 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Major Pharmaceuticals | 4cee8622-7d59-4794-8e32-54f7aac1d923 | 2025-09-22 | Warnings, Adverse reactions | 091179 ANDA091179 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 12400c65-f93b-47a5-8167-1fb14337130b | 2025-01-07 | Warnings, Adverse reactions | 091179 ANDA091179 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 05907a49-537f-4bf2-8a5f-5e905f19fece | 2024-10-30 | Warnings, Adverse reactions | 091179 ANDA091179 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60760-830-20 | 60760083020 | 20 TABLET in 1 BOTTLE, PLASTIC (60760-830-20) | 20 tablet | 2012-12-19 | 0000-00-00 | No | No | Current |