Promethazine Hydrochloride

Product NDC: 33261-865
11-digit product format: 332610865
Labeler code: 33261
Product ID: 33261-865_e06b299b-b1b6-40db-94b3-30d476196771
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA040712
Marketing category: ANDA
Marketing start: 2012-07-17
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: 2019-12-31
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	33261-865		I	Inactivated by FDA		2026-08-07
excluded package	package	33261-865	33261-865-30	I	Inactivated by FDA		2026-08-07

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 · 42 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	33261-865-30	`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	33261-865-30	`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	33261-865-30	`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	33261-865-30	`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	33261-865-30	`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	33261-865-30	`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	33261-865-30	`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	33261-865-30	`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	33261-865-30	`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	33261-865-30	`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	33261-865-30	`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	33261-865-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-865-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-865-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-865-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	33261-865-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	33261-865-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	33261-865-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	33261-865-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	33261-865-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	33261-865-30	`9bebd1f3094a…`	`5416666fcb17…`

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
A040712-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31
A040712-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04
A040712-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040712-001	AB
A040712-002	AB
A040712-003	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	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`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	A040712-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040712-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040712-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040712-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33261-865-30	2020-01-31	C162847	48780-1	9d75b9d0-6dc0-f424-e053-dadaa90a57ce	Unknown Title

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33261-865-30	Promethazine Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-865-30	EA - Each	33261-865	51054ffc-3ec1-4c46-9091-8c7572737109	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	8
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	8
METHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	4GFU244C4J	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-865	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	9	Legacy NDC, 1 package rows	20160813_857dd0a8-3e23-423c-9b5e-9a8779b4c7d0.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 1 · 16 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.	6bcaa89f-5f14-dc45-e053-2a91aa0aac54	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	804e2525-d61f-7bed-e053-2991aa0a5daa	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f93ca67d-362a-473f-8296-2952da77c074	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	KVK-Tech, Inc.	7a137adf-39b7-4b14-80da-c3cac9ad562a	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	d9cb1a44-d646-d9e9-e053-2995a90a24ff	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7e5715cf-056f-4095-e053-2991aa0ad3e5	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	a7b1e8b2-6f20-4096-87c7-cf349ed4f7b9	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b54439a3-1d01-4c5f-8508-731790ae215b	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b96904e7-cc67-4abc-b946-8423f3f897ff	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	2c9a4767-23c4-4a1c-bb4c-2bad1351c270	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
Promethazine	PROMETHAZINE	PharmPak, Inc.	4f681538-7ac4-484c-9e6d-b571d73b9e0b	2022-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	29a8b172-1bad-40db-8d73-1fe7fb309cff	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992438	promethazine HCl 12.5 MG Oral Tablet	PSN	857dd0a8-3e23-423c-9b5e-9a8779b4c7d0	9
992447	promethazine HCl 25 MG Oral Tablet	PSN	857dd0a8-3e23-423c-9b5e-9a8779b4c7d0	9
992438	promethazine hydrochloride 12.5 MG Oral Tablet	SCD	857dd0a8-3e23-423c-9b5e-9a8779b4c7d0	9
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	857dd0a8-3e23-423c-9b5e-9a8779b4c7d0	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-865-30	33261086530	30 in 1 BOTTLE, PLASTIC	Historical