promethazine hydrochloride
- Product NDC
- 71335-0109
- 11-digit product format
- 713350109
- Labeler code
- 71335
- Product ID
- 71335-0109_360612c6-6c9d-424e-a676-94055c5b53a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA040863
- Marketing category
- ANDA
- Marketing start
- 2009-01-27
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 13 mg/1
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 product | product | 71335-0109 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 71335-0109 | 71335-0109-0 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0109 | 71335-0109-1 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0109 | 71335-0109-2 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0109 | 71335-0109-3 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0109 | 71335-0109-5 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0109 | 71335-0109-6 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0109 | 71335-0109-7 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0109 | 71335-0109-8 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0109 | 71335-0109-9 | D | Discontinued by firm | 2026-10-05 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0109-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0109-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0109-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0109-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0109-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0109-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0109-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0109-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0109-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0109-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0109-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0109-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0109-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0109-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0109-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0109-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0109-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0109-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0109-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0109-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0109-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0109-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0109-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0109-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0109-7 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0109-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0109-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0109-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0109-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0109-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0109-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0109-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0109-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0109-7 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0109-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0109-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0109-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0109-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0109-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0109-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0109-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0109-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0109-7 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0109-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0109-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0109-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0109-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0109-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0109-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0109-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0109-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0109-7 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0109-9 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0109-6 | cdf11ea48f46… | ba0047e9e063… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040863-001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | ||
| A040863-002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | ||
| A040863-003 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040863-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040863-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040863-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040863-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040863-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040863-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040863-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040863-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040863-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040863-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040863-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040863-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040863-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040863-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040863-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040863-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040863-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040863-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040863-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040863-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040863-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040863-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040863-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040863-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040863-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040863-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040863-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040863-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A040863-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A040863-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040863-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A040863-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A040863-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040863-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A040863-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A040863-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040863-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A040863-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A040863-003 | AB | 1 | ea99ee380514… |
| 2023-12-20 04:57 UTC | 2023-12 | A040863-001 | AB | 1 | ea1830bbd6c7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-0109-0 | EA - Each | 71335-0109 | c745cbcc-20ca-46e3-85ce-0acb1ed9926f | 1 | 2018-03-08 |
| 71335-0109-1 | EA - Each | 71335-0109 | 4334a8e1-d7de-4091-b545-97241bb81bd2 | 1 | 2018-03-08 |
| 71335-0109-2 | EA - Each | 71335-0109 | 0bcb9722-7b25-40c1-8327-c596e2b0667e | 1 | 2018-03-08 |
| 71335-0109-3 | EA - Each | 71335-0109 | 4f97bbe5-1d1e-4aba-97e6-29249315202d | 1 | 2018-03-08 |
| 71335-0109-5 | EA - Each | 71335-0109 | 3bfcb17d-cf1a-47d4-bb52-0045beae6ad6 | 1 | 2018-03-08 |
| 71335-0109-6 | EA - Each | 71335-0109 | b324dadf-4d2e-43db-81f2-dbffd1d2197c | 1 | 2018-03-08 |
| 71335-0109-7 | EA - Each | 71335-0109 | 6d3c4e33-bc76-4c07-90d6-17b0a8249e0e | 1 | 2018-03-08 |
| 71335-0109-8 | EA - Each | 71335-0109 | c736be98-0164-4b4b-91ca-e0bb8a89a759 | 1 | 2018-03-08 |
| 71335-0109-9 | EA - Each | 71335-0109 | e1aa601f-75a7-4a07-ac3a-743c957693d4 | 1 | 2018-03-08 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-0109-0 | 71335010900 | 30 TABLET in 1 BOTTLE (71335-0109-0) | 30 tablet | 2016-06-22 | 0000-00-00 | No | No | Current |
| 71335-0109-1 | 71335010901 | 12 TABLET in 1 BOTTLE (71335-0109-1) | 12 tablet | 2016-06-22 | 0000-00-00 | No | No | Current |
| 71335-0109-2 | 71335010902 | 4 TABLET in 1 BOTTLE (71335-0109-2) | 4 tablet | 2016-06-22 | 0000-00-00 | No | No | Current |
| 71335-0109-3 | 71335010903 | 2 TABLET in 1 BOTTLE (71335-0109-3) | 2 tablet | 2016-06-22 | 0000-00-00 | No | No | Current |
| 71335-0109-5 | 71335010905 | 6 TABLET in 1 BOTTLE (71335-0109-5) | 6 tablet | 2016-06-22 | 0000-00-00 | No | No | Current |
| 71335-0109-6 | 71335010906 | 10 TABLET in 1 BOTTLE (71335-0109-6) | 10 tablet | 2016-06-22 | 0000-00-00 | No | No | Current |
| 71335-0109-7 | 71335010907 | 40 TABLET in 1 BOTTLE (71335-0109-7) | 40 tablet | 2016-06-22 | 0000-00-00 | No | No | Current |
| 71335-0109-8 | 71335010908 | 20 TABLET in 1 BOTTLE (71335-0109-8) | 20 tablet | 2016-06-22 | 0000-00-00 | No | No | Current |
| 71335-0109-9 | 71335010909 | 60 TABLET in 1 BOTTLE (71335-0109-9) | 60 tablet | 2016-06-22 | 0000-00-00 | No | No | Current |