Promethazine Hydrochloride

Product NDC: 0641-0949
11-digit product format: 006410949
Labeler code: 0641
Product ID: 0641-0949_9b956a99-5a3c-4932-9d4e-804bbea8cee4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA083312
Marketing category: ANDA
Marketing start: 1973-09-19
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 50 mg/mL
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0641-0949		D	Discontinued by firm		2026-08-03
excluded package	package	0641-0949	0641-0949-35	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 · 24 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	0641-0949-35	`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	0641-0949-35	`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	0641-0949-35	`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	0641-0949-35	`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	0641-0949-35	`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	0641-0949-35	`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	0641-0949-35	`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	0641-0949-35	`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	0641-0949-35	`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	0641-0949-35	`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	0641-0949-35	`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	0641-0949-35	`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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Promethazine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R61ZEH7I1I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992460	Internal RxNorm lookup
992858	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d545105f-27dc-4820-b0b1-fcf17e0be0f0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
3036445d-7d13-4411-a100-f2ac5ab8a276	Product name	1	20240110
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
2e7222fb-e3f1-febd-962f-ddbb495d6b5f	Product name	2	20220126
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
4f881de7-085a-407e-abc2-faa3c0127432	Product name	1	20170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d51697af-7f97-0559-95d1-fe94f3f031d5	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-0949-31	Promethazine Hydrochloride	1 mL in 1 AMPULE	INJECTION	1		6
0641-0949-35	Promethazine Hydrochloride	25 in 1 CARTON	INJECTION	25		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-0949-31	ML - Milliliter	0641-0949	39f806af-98ce-4c30-97c3-ab6d1e1608c7	1	2012-07-24
0641-0949-35	ML - Milliliter	0641-0949	8d0ac131-bc02-469a-a10a-7f1f12e30b5c	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.]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-0949	PROMETHAZINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240606_d545105f-27dc-4820-b0b1-fcf17e0be0f0.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 · 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 ndc (product): 0641-0949
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992460	promethazine HCl 25 MG in 1 ML Injection	PSN	d545105f-27dc-4820-b0b1-fcf17e0be0f0	6
992858	promethazine HCl 50 MG in 1 ML Injection	PSN	d545105f-27dc-4820-b0b1-fcf17e0be0f0	6
992460	1 ML promethazine hydrochloride 25 MG/ML Injection	SCD	d545105f-27dc-4820-b0b1-fcf17e0be0f0	6
992858	1 ML promethazine hydrochloride 50 MG/ML Injection	SCD	d545105f-27dc-4820-b0b1-fcf17e0be0f0	6
992460	promethazine HCl 25 MG per 1 ML Injection	SY	d545105f-27dc-4820-b0b1-fcf17e0be0f0	6
992858	promethazine HCl 50 MG per 1 ML Injection	SY	d545105f-27dc-4820-b0b1-fcf17e0be0f0	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-0949-31	00641094931	1 mL in 1 AMPULE	1 ml					Historical
0641-0949-35	00641094935	25 AMPULE in 1 CARTON (0641-0949-35) / 1 mL in 1 AMPULE (0641-0949-31)	25 ampule	1973-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride Injection, USP	Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	2025-06-30	HUMAN PRESCRIPTION DRUG LABEL	6