Promethazine Hydrochloride

Product NDC: 70934-353
11-digit product format: 709340353
Labeler code: 70934
Product ID: 70934-353_b7afbb8d-8e30-5305-e053-2a95a90a8395
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA040596
Marketing category: ANDA
Marketing start: 2019-05-01
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: 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.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70934-353		D	Discontinued by firm	2026-10-05
excluded package	package	70934-353	70934-353-12	D	Discontinued by firm	2026-10-05
excluded package	package	70934-353	70934-353-20	D	Discontinued by firm	2026-10-05
excluded package	package	70934-353	70934-353-30	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.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-353-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-353-12	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-353-20	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-353-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-353-12	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-353-20	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-353-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-353-12	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-353-20	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-353-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-353-12	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-353-20	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-353-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-353-12	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-353-20	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-353-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-353-12	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-353-20	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-353-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-353-12	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-353-20	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70934-353-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70934-353-12	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70934-353-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70934-353-30	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70934-353-12	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70934-353-20	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70934-353-30	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70934-353-12	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70934-353-20	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70934-353-30	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70934-353-12	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70934-353-20	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70934-353-30	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70934-353-12	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70934-353-20	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70934-353-12	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70934-353-20	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70934-353-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70934-353-12	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70934-353-20	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70934-353-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70934-353-12	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70934-353-20	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70934-353-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	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#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040596-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040596-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040596-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040596-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040596-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040596-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70934-353-12	2023-02-07	Promethazine Hydrochloride Tablets USP
70934-353-20	2023-02-07	Promethazine Hydrochloride Tablets USP
70934-353-30	2023-02-07	Promethazine Hydrochloride Tablets USP
70934-353-12	2022-01-28	Promethazine Hydrochloride Tablets USP
70934-353-20	2022-01-28	Promethazine Hydrochloride Tablets USP
70934-353-30	2022-01-28	Promethazine Hydrochloride Tablets USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70934-353-12	EA - Each	70934-353	5438df83-9c01-49d5-80ab-71ddf7e3dc53	1	2023-01-09

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.

Matched openFDA labels page 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	84899861-8fed-536d-e053-2991aa0a42b2	2024-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	a4fbc2d8-19b3-4556-b0b9-6e7a14cd4c36	2024-09-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	ea490539-007b-47b1-bef9-22de02ae7c64	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8749824b-6d66-430d-e053-2995a90a2db8	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	da246971-20b8-b46e-8366-9700d3604cf1	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Asclemed USA, Inc.	b4985d9d-1aa0-4b36-bc98-6a5410ad9bad	2024-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	c0c0d4f0-8396-485b-a585-71df01491f6f	2023-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	dcb1694a-8451-403c-b848-edb89ba17020	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	87429921-00d2-42c7-9e99-600e8075b8ce	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	59b906c6-2ccc-416e-b3ee-db09bf553146	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE	58-33-3	PROMETHAZINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-353-12	70934035312	12 TABLET in 1 BOTTLE, PLASTIC (70934-353-12)	12 tablet	2019-05-01	0000-00-00	No	No	Current
70934-353-20	70934035320	20 TABLET in 1 BOTTLE, PLASTIC (70934-353-20)	20 tablet	2019-05-01	0000-00-00	No	No	Current
70934-353-30	70934035330	30 TABLET in 1 BOTTLE, PLASTIC (70934-353-30)	30 tablet	2019-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride Tablets USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL	2