promethazine hydrochloride

Product NDC: 63187-038
Requested package NDC: 63187-038-30
11-digit product format: 631870038
Labeler code: 63187
Product ID: 63187-038_52266eb3-3fb1-4838-b2e1-bbe553ff7cf2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: promethazine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA040863
Marketing category: ANDA
Marketing start: 2009-01-27
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63187-038	63187-038-30	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-038	63187-038-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-038	63187-038-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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	Approval date
A040863-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30
A040863-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30
A040863-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040863-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040863-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040863-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040863-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040863-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040863-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040863-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040863-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040863-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040863-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040863-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040863-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040863-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040863-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040863-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040863-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040863-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040863-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040863-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040863-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040863-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040863-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040863-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040863-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040863-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040863-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040863-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040863-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040863-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040863-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040863-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040863-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040863-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040863-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040863-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040863-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040863-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040863-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040863-003	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A040863-001	AB	1	`ea1830bbd6c7…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-038-10	EA - Each	63187-038	87b00f84-cb76-49c5-8b4f-f73030cdb812	1	2015-12-02
63187-038-30	EA - Each	63187-038	7571469b-f3d0-44da-9d52-179e44ae7655	1	2016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	5
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-038	PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	8	Legacy NDC	20191121_9910dd1f-297f-48e6-9a0a-30cd978bb90d.zip

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
63187-038-30	63187003830	30 TABLET in 1 BOTTLE (63187-038-30)	30 tablet	2018-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
promethazine hydrochloride - Proficient Rx LP	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	8