Promethazine Hydrochloride

Product NDC: 63739-213
11-digit product format: 637390213
Labeler code: 63739
Product ID: 63739-213_c05609d7-c899-1b0e-e053-2a95a90a999b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: McKesson Corporation dba SKY Packaging
Application: ANDA084176
Marketing category: ANDA
Marketing start: 1975-12-19
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: 2022-12-31
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	63739-213		D	Discontinued by firm		2026-10-05
excluded package	package	63739-213	63739-213-10	D	Discontinued by firm		2026-10-05

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 · 22 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	63739-213-10	`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	63739-213-10	`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	63739-213-10	`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	63739-213-10	`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	63739-213-10	`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	63739-213-10	`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	63739-213-10	`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	63739-213-10	`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	63739-213-10	`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	63739-213-10	`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	63739-213-10	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
A084176-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A084176-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22
A084176-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, 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
A084176-001	AB
A084176-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A084176-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084176-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084176-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084176-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084176-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084176-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084176-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084176-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084176-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084176-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084176-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084176-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084176-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084176-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084176-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084176-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084176-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084176-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084176-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084176-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084176-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084176-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084176-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084176-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084176-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084176-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084176-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084176-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084176-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084176-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084176-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084176-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084176-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084176-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084176-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084176-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084176-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084176-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084176-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084176-003	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63739-213-10	2020-07-22	C162847	48780-1	ab0e2407-3058-f274-e053-dbdaa90a6471	Promethazine Hydrochloride Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-213-10	EA - Each	63739-213	89affebc-8b30-4931-8c7f-2fc0859a310b	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 TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROMETHAZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	PROMETHAZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	PROMETHAZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-213-10	63739021310	10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-213-10) > 10 TABLET in 1 BLISTER PACK	10 blister pack	1975-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride Tablets, USP	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2023-12-14	HUMAN PRESCRIPTION DRUG LABEL	10