Promethazine Hydrochloride

Product NDC: 51655-112
11-digit product format: 516550112
Labeler code: 51655
Product ID: 51655-112_cb8e448c-9616-462d-a412-94af74c2ad17
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Pharmaceuticals
Application: ANDA040596
Marketing category: ANDA
Marketing start: 2014-03-03
Marketing end: 0000-00-00
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 13 mg/1
Pharmacologic classes: Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51655-112		D	Discontinued by firm		2026-08-03
excluded package	package	51655-112	51655-112-10	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.

Historic NDC status page 1 of 1 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51655-112-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51655-112-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51655-112-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51655-112-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51655-112-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51655-112-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51655-112-10	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51655-112-10	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51655-112-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51655-112-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51655-112-10	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51655-112-10	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51655-112-10	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51655-112-10	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51655-112-10	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
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	51655-112-10	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	51655-112-10	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	51655-112-10	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	51655-112-10	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	51655-112-10	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	51655-112-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	51655-112-10	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 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
2026-02-19 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#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-112-10	2026-01-04	C162847	48780-1	9d75b9d0-4741-f424-e053-dadaa90a57ce	1ea20a7e-ebf1-4ba3-a7dd-61e0483e3b23
51655-112-10	2020-01-31	C162847	48780-1	9d75b9d0-4741-f424-e053-dadaa90a57ce	1ea20a7e-ebf1-4ba3-a7dd-61e0483e3b23

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-112	PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	1	Legacy NDC	20140611_1ea20a7e-ebf1-4ba3-a7dd-61e0483e3b23.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.

Matched openFDA labels page 1 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	9e4e57fa-4ce3-4b7b-be5a-381801ed0386	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Sportpharm LLC	4156e780-7ecf-bcae-e063-6394a90a2ae2	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	ASCLEMED USA INC.	4d30e587-6d59-4cf5-ab45-c7639f759df9	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	5590f356-0904-58f6-e063-6294a90a6ad5	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	DIRECT RX	bae9c9c1-107f-0fcb-e053-2a95a90a75b2	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Phenergan	PROMETHAZINE HCL	Direct_Rx	eec705f7-123a-7926-e053-2a95a90af46d	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	adb04635-584f-4fef-98ca-2574be312a73	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	American Health Packaging	a8fe4bc5-961b-4441-b8e2-ef93e4e137b6	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	American Health Packaging	57b4bf23-c563-4357-9dcf-066cbc1280e4	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	6728bb41-5d50-4abb-bb73-993dcc16ee66	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	974208c8-4aad-4fb9-991b-cf3085034272	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	BluePoint Laboratories	44cd6d46-fbb9-4836-9426-d8ce2cb6d66d	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Coupler LLC	2d996287-9eed-265a-e063-6294a90a6969	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f4c23037-e415-7604-e053-2995a90a5bb6	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Zydus Lifesciences Limited	4eaa8291-9cde-4205-857b-925ea8d618ba	2024-12-04		Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	6aa6bfcc-024b-4ee2-a586-6c4ca879cea4	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	69eea039-0098-4e2f-a832-152583b16f05	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b7137912-d119-4899-9c93-09c1c625f290	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
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

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride - Northwind Pharmaceuticals	Northwind Pharmaceuticals	2014-06-04	HUMAN PRESCRIPTION DRUG LABEL	1