Promethazine Hydrochloride

Product NDC: 10135-495
Requested package NDC: 10135-495-01
11-digit product format: 101350495
Labeler code: 10135
Product ID: 10135-495_ecac401c-0a8f-d482-e053-2995a90ad3c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: promethazine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA091179
Marketing category: ANDA
Marketing start: 2016-10-01
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: 2023-12-31
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	10135-495	10135-495-01	I	Inactivated by FDA		2026-08-11

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 · 1 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
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10135-495	10135-495-01	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A091179-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13
A091179-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13
A091179-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091179-001	AB
A091179-002	AB
A091179-003	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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091179-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2010-12-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091179-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2010-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091179-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2010-12-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A091179-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091179-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091179-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091179-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091179-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091179-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091179-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091179-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091179-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091179-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091179-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091179-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091179-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091179-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091179-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091179-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091179-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091179-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091179-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091179-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091179-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091179-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091179-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091179-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091179-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091179-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091179-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091179-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091179-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091179-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091179-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091179-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091179-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091179-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091179-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091179-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091179-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091179-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091179-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091179-001	AB	1	`8072bd15b7f6…`

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, Related label table
NDC	Effective	Related label
10135-495-01	2026-01-29	Promethazine Hydrochloride
10135-495-10	2026-01-29	Promethazine Hydrochloride
10135-495-01	2021-02-12	Promethazine Hydrochloride
10135-495-10	2021-02-12	Promethazine Hydrochloride
10135-495-01	2021-01-29	Promethazine Hydrochloride
10135-495-10	2021-01-29	Promethazine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-495-01	Promethazine Hydrochloride	100 in 1 BOTTLE	TABLET	100		8
10135-495-10	Promethazine Hydrochloride	1000 in 1 BOTTLE	TABLET	1000		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-495-01	EA - Each	10135-495	3ca15217-096d-4c11-b8a3-50c0d7b56dd0	1	2017-06-15
10135-495-10	EA - Each	10135-495	7ff61d7b-f2e8-4dbd-955e-59d6652ef808	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-495	PROMETHAZINE HYDROCHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]	8	Legacy NDC, 2 package rows	20231123_7834998b-2c53-4edc-97d9-508f7cc92f7c.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	bf951b5b-6e38-44a9-895e-0d60c6b9d343	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091179 application number: ANDA091179
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	81fd29a9-c090-49ba-8b48-bd3656ca0c92	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091179 application number: ANDA091179
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	075f052e-7f38-7f75-e063-6394a90a512b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091179 application number: ANDA091179
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	ba4ec2d8-1da4-473b-9ef8-57051cb2c0f7	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091179 application number: ANDA091179
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	0b5734b8-6a52-44ff-ac29-9a91a4335394	2025-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091179 application number: ANDA091179
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	e16238dc-9292-49ac-b80f-8afeccb88bc5	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091179 application number: ANDA091179
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Major Pharmaceuticals	4cee8622-7d59-4794-8e32-54f7aac1d923	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091179 application number: ANDA091179
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	12400c65-f93b-47a5-8167-1fb14337130b	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091179 application number: ANDA091179
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	05907a49-537f-4bf2-8a5f-5e905f19fece	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091179 application number: ANDA091179

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	7834998b-2c53-4edc-97d9-508f7cc92f7c	8
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	7834998b-2c53-4edc-97d9-508f7cc92f7c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-495-01	10135049501	100 TABLET in 1 BOTTLE (10135-495-01)	100 tablet	2016-10-01	0000-00-00	No	No	Current