Promethazine Hydrochloride

Product NDC: 68071-3254
11-digit product format: 680713254
Labeler code: 68071
Product ID: 68071-3254_505e166f-e420-1b8c-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA040428
Marketing category: ANDA
Marketing start: 2015-06-01
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	68071-3254		D	Discontinued by firm	2026-08-03
excluded package	package	68071-3254	68071-3254-2	D	Discontinued by firm	2026-08-03
excluded package	package	68071-3254	68071-3254-4	D	Discontinued by firm	2026-08-03
excluded package	package	68071-3254	68071-3254-6	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.

Historic NDC status page 1 of 1 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
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	68071-3254-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-3254-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-3254-4	`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	68071-3254-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-3254-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-3254-4	`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	68071-3254-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-3254-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-3254-4	`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	68071-3254-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-3254-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-3254-4	`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	68071-3254-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-3254-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-3254-4	`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	68071-3254-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-3254-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-3254-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3254-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3254-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3254-4	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3254-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3254-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3254-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3254-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3254-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3254-4	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-3254-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-3254-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-3254-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-3254-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-3254-6	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-3254-4	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-3254-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-3254-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-3254-4	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040428-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05
A040428-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040428-001	AB
A040428-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
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	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A040428-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040428-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040428-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040428-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040428-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040428-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040428-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040428-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040428-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040428-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040428-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040428-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040428-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040428-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040428-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040428-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040428-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040428-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040428-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040428-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040428-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040428-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040428-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040428-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040428-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040428-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040428-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040428-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040428-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040428-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040428-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040428-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040428-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040428-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040428-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040428-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040428-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040428-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040428-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040428-002	AB	1	`782e0a99824c…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97	2025-10-20	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 040428 application number: ANDA040428
PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	5f079815-f48b-8b21-2130-7f791d967c9a	2023-11-30	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 040428 application number: ANDA040428

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 SUPPOSITORIES, USP	NuCare Pharmaceuticals, Inc.	2017-05-25	HUMAN PRESCRIPTION DRUG LABEL	1