Promethazine Hydrochloride
- Product NDC
- 70518-1306
- 11-digit product format
- 705181306
- Labeler code
- 70518
- Product ID
- 70518-1306_50270206-60a2-f62b-e063-6294a90a665f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2018-07-16
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | 70518-1306 | 70518-1306-0 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-1306 | 70518-1306-1 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-1306 | 70518-1306-3 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-1306 | 70518-1306-5 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-1306 | 70518-1306-6 | D | Discontinued by firm | 2026-08-03 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-1306-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-1306-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-1306-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-1306-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-1306-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-1306-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-1306-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-1306-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-1306-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-1306-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 70518-1306-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 70518-1306-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 70518-1306-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 70518-1306-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 70518-1306-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 70518-1306-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 70518-1306-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 70518-1306-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 70518-1306-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 70518-1306-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 70518-1306-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 70518-1306-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 70518-1306-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 70518-1306-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 70518-1306-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 70518-1306-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 70518-1306-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 70518-1306-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 70518-1306-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 70518-1306-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 70518-1306-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 70518-1306-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 70518-1306-6 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 70518-1306-0 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 70518-1306-5 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 70518-1306-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 70518-1306-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 70518-1306-6 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 70518-1306-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 70518-1306-5 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 70518-1306-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 70518-1306-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 70518-1306-6 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 70518-1306-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 70518-1306-5 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 70518-1306-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 70518-1306-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 70518-1306-6 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 70518-1306-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 70518-1306-5 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 70518-1306-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 70518-1306-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 70518-1306-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 70518-1306-5 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 70518-1306-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Promethazine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PROMETHAZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R61ZEH7I1I | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 992447 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9e4e57fa-4ce3-4b7b-be5a-381801ed0386 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3036445d-7d13-4411-a100-f2ac5ab8a276 | Product name | 1 | 20240110 |
| 2e7222fb-e3f1-febd-962f-ddbb495d6b5f | Product name | 2 | 20220126 |
| 09d8330d-4fec-be98-3a66-f985140646b2 | Product name | 2 | 20210513 |
| 4f881de7-085a-407e-abc2-faa3c0127432 | Product name | 1 | 20170811 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| d51697af-7f97-0559-95d1-fe94f3f031d5 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-1306-0 | Promethazine Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 21 | |
| 70518-1306-1 | Promethazine Hydrochloride | 6 in 1 BOTTLE, PLASTIC | TABLET | 6 | 21 | |
| 70518-1306-2 | Promethazine Hydrochloride | 15 in 1 BOTTLE, PLASTIC | TABLET | 15 | 21 | |
| 70518-1306-3 | Promethazine Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 21 | |
| 70518-1306-4 | Promethazine Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 21 | |
| 70518-1306-5 | Promethazine Hydrochloride | 15 in 1 BOTTLE, PLASTIC | TABLET | 15 | 21 | |
| 70518-1306-6 | Promethazine Hydrochloride | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | 21 | |
| 70518-1306-7 | Promethazine Hydrochloride | 50 in 1 BOX | TABLET | 50 | 21 | |
| 70518-1306-8 | Promethazine Hydrochloride | 1 in 1 POUCH | TABLET | 1 | 21 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-1306 | PROMETHAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 18 | Current NDC, Legacy NDC, 9 package rows | 20250510_9e4e57fa-4ce3-4b7b-be5a-381801ed0386.zip |
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 70518-1306 |
| 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 |
| Phenergan | PROMETHAZINE HCL | Direct_Rx | eec705f7-123a-7926-e053-2a95a90af46d | 2026-03-05 | Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | REMEDYREPACK INC. | adb04635-584f-4fef-98ca-2574be312a73 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992447 | promethazine HCl 25 MG Oral Tablet | PSN | 9e4e57fa-4ce3-4b7b-be5a-381801ed0386 | 21 |
| 992447 | promethazine hydrochloride 25 MG Oral Tablet | SCD | 9e4e57fa-4ce3-4b7b-be5a-381801ed0386 | 21 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-1306-0 | 70518130600 | 30 in 1 BLISTER PACK | Historical | |||||
| 70518-1306-1 | 70518130601 | 6 TABLET in 1 BOTTLE, PLASTIC (70518-1306-1) | 6 tablet | 2020-09-09 | 0000-00-00 | No | No | Current |
| 70518-1306-2 | 70518130602 | 15 TABLET in 1 BOTTLE, PLASTIC (70518-1306-2) | 15 tablet | 2020-12-14 | 0000-00-00 | No | No | Current |
| 70518-1306-3 | 70518130603 | 30 TABLET in 1 BLISTER PACK (70518-1306-3) | 30 tablet | 2021-09-21 | 0000-00-00 | No | No | Current |
| 70518-1306-4 | 70518130604 | 30 TABLET in 1 BLISTER PACK (70518-1306-4) | 30 tablet | 2023-01-17 | No | No | Current | |
| 70518-1306-5 | 70518130605 | 15 in 1 BOTTLE, PLASTIC | Historical | |||||
| 70518-1306-6 | 70518130606 | 10 in 1 BOTTLE, PLASTIC | Historical | |||||
| 70518-1306-7 | 70518130607 | 50 POUCH in 1 BOX (70518-1306-7) / 1 TABLET in 1 POUCH (70518-1306-8) | 50 pouch | 2026-04-22 | No | No | Current | |
| 70518-1306-8 | 70518130608 | 1 in 1 POUCH | Historical |