Promethazine Hydrochloride

Product NDC: 0641-6099
11-digit product format: 006416099
Labeler code: 0641
Product ID: 0641-6099_42359b1f-53f4-499c-871f-1c0485d56d2c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: West-ward Pharmaceutical Corp.
Application: ANDA083312
Marketing category: ANDA
Marketing start: 1973-09-19
Marketing end: 0000-00-00
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 25 mg/mL
Pharmacologic classes: Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	0641-6099		D	Discontinued by firm		2026-08-03
excluded package	package	0641-6099	0641-6099-25	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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	D	Discontinued by firm	`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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	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	0641-6099-25	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0641-6099-25	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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
A083312-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
A083312-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A083312-001	AP
A083312-002	AP

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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`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	A083312-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083312-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083312-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083312-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083312-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083312-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083312-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083312-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083312-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083312-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083312-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083312-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083312-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083312-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083312-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083312-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083312-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083312-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083312-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083312-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083312-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083312-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083312-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083312-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083312-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083312-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083312-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083312-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083312-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083312-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083312-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083312-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083312-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083312-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083312-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083312-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083312-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083312-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083312-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083312-002	AP	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0641-6099-25	2024-06-05	C162847	48780-1	960f7f55-d58f-8e05-e053-dbdaa90a074a	Promethazine Hydrochloride Injection, USP Rx only
0641-6099-25	2019-10-29	C162847	48780-1	960f7f55-d58f-8e05-e053-dbdaa90a074a	Promethazine Hydrochloride Injection, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6099-01	ML - Milliliter	0641-6099	44485d47-ac32-4783-97cd-c5cb391cca8d	1	2012-07-24
0641-6099-25	ML - Milliliter	0641-6099	c055dafe-ee66-446f-963b-9f3d22150d8a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
PHENOL	INACTIVE INGREDIENT	339NCG44TV	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Henry Schein, Inc.	7fa840ad-10e7-4faf-9325-451648604161	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	7ce351d8-47be-4937-aad2-153208c93b53	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	ProPharma Distribution	38673af1-112e-9ddd-e063-6294a90af465	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Henry Schein, Inc.	d7675718-0a57-41ff-a771-79afc12150aa	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Henry Schein, Inc.	c525cb2c-9a01-4a9b-ad2c-08630719953d	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	13d9e59d-eadb-41d5-9f47-9c11a6efb31c	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	d545105f-27dc-4820-b0b1-fcf17e0be0f0	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	6f7e47cc-f823-4336-8107-f980e3049617	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	4bf3912c-8339-401e-9711-dad6acf15f11	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	481866da-a712-48a5-853f-8e84aacaab6d	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	b0d5abba-6fae-4f3c-b990-dd9c83c7b5a9	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	365138a6-28d8-4881-a3e9-02c80aaf83e8	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a	2024-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	7447e8c6-c198-cd2d-e053-2a91aa0a3895	2024-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	677b5fc5-94be-638b-e053-2991aa0a7f97	2023-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	dc8b50de-e4f6-607f-e053-2995a90a2902	2023-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	c930985b-bba3-4f3a-a1ae-1d808670efde	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312

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 Injection, USP Rx only	West-ward Pharmaceutical Corp. \| West-ward Pharmaceutical Corp	2011-09-15	HUMAN PRESCRIPTION DRUG LABEL	5