PROMETHAZINE HYDROCHLORIDE

Product NDC: 61919-630
Requested package NDC: 61919-630-10
11-digit product format: 619190630
Labeler code: 61919
Product ID: 61919-630_9cac9b3f-a50f-0219-e053-2995a90aadbc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROMETHAZINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA040863
Marketing category: ANDA
Marketing start: 2016-03-02
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: 2021-12-31
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	61919-630	61919-630-10	I	Inactivated by FDA		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 · 19 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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 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
61919-630-10	2022-01-28	C162847	48780-1	d6a99b39-ee41-a426-e053-dadaa90af4c2	PROMETHAZINE HYDROCHLORIDE 25mg
61919-630-60	2020-01-31	C162847	48780-1	9d75b9d0-e257-f424-e053-dadaa90a57ce	PROMETHAZINE HYDROCHLORIDE 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-630-10	PROMETHAZINE HYDROCHLORIDE	10 in 1 BOTTLE	TABLET	10		2
61919-630-60	PROMETHAZINE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-630-10	EA - Each	61919-630	fad25e38-6a94-485e-96cf-fced51e3d11d	1	2016-09-02
61919-630-60	EA - Each	61919-630	6315556c-a791-4b2d-bb62-6decb5722607	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-630	PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]	2	Legacy NDC, 1 package rows	20200130_2ebb4414-e3f4-3d8d-e054-00144ff88e88.zip
61919-630	PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]	1	Legacy NDC, 1 package rows	20160222_2c5d4ccc-5d67-0329-e054-00144ff88e88.zip

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
992447	promethazine HCl 25 MG Oral Tablet	PSN	2ebb4414-e3f4-3d8d-e054-00144ff88e88	2
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	2ebb4414-e3f4-3d8d-e054-00144ff88e88	2
992447	promethazine HCl 25 MG Oral Tablet	PSN	2c5d4ccc-5d67-0329-e054-00144ff88e88	1
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	2c5d4ccc-5d67-0329-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-630-10	61919063010	10 TABLET in 1 BOTTLE (61919-630-10)	10 tablet	2016-03-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE HYDROCHLORIDE 25mg	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
PROMETHAZINE HYDROCHLORIDE 25mg	DIRECT RX	2016-02-22	HUMAN PRESCRIPTION DRUG LABEL	1