Promethazine Hydrochloride

Product NDC: 68382-041
11-digit product format: 683820041
Labeler code: 68382
Product ID: 68382-041_d461a206-0842-428f-ad9b-a4aac8193fe9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA040596
Marketing category: ANDA
Marketing start: 2005-12-14
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A040596-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18
A040596-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18
A040596-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040596-001	AB
A040596-002	AB
A040596-003	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	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`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	A040596-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040596-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040596-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040596-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040596-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040596-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040596-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040596-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040596-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040596-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040596-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040596-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040596-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040596-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040596-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040596-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040596-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040596-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040596-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040596-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040596-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040596-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040596-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040596-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040596-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040596-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040596-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040596-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040596-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040596-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040596-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040596-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040596-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040596-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040596-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040596-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040596-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040596-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040596-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040596-001	AB	1	`8072bd15b7f6…`

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	25 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992438	Internal RxNorm lookup
992447	Internal RxNorm lookup
992475	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
c0c0d4f0-8396-485b-a585-71df01491f6f	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68382-041-01	Promethazine Hydrochloride	100 in 1 BOTTLE	TABLET	100	8
68382-041-05	Promethazine Hydrochloride	500 in 1 BOTTLE	TABLET	500	8
68382-041-10	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
68382-041-01	EA - Each	68382-041	16782f65-a21c-4a53-857c-9715cc63ccc2	1	2012-07-24
68382-041-05	EA - Each	68382-041	e6ab47c3-786c-4ff6-bf66-8867bbe73030	1	2022-11-07
68382-041-10	EA - Each	68382-041	be2eca3b-e059-4a50-98b1-b5411c3020a5	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 [AMERICAN HEALTH PACKAGING]	4
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	PROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	2
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	2
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PROMETHAZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PROMETHAZINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	PROMETHAZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	PROMETHAZINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-041	PROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS USA INC.]	8	Current NDC, Legacy NDC, 3 package rows	20231110_c0c0d4f0-8396-485b-a585-71df01491f6f.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Coupler LLC	55f618d1-4466-3200-e063-6394a90a89a8	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	9e4e57fa-4ce3-4b7b-be5a-381801ed0386	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Sportpharm LLC	4156e780-7ecf-bcae-e063-6394a90a2ae2	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	ASCLEMED USA INC.	4d30e587-6d59-4cf5-ab45-c7639f759df9	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	5590f356-0904-58f6-e063-6294a90a6ad5	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	DIRECT RX	bae9c9c1-107f-0fcb-e053-2a95a90a75b2	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Phenergan	PROMETHAZINE HCL	Direct_Rx	eec705f7-123a-7926-e053-2a95a90af46d	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	adb04635-584f-4fef-98ca-2574be312a73	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	American Health Packaging	a8fe4bc5-961b-4441-b8e2-ef93e4e137b6	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	American Health Packaging	57b4bf23-c563-4357-9dcf-066cbc1280e4	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	6728bb41-5d50-4abb-bb73-993dcc16ee66	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	974208c8-4aad-4fb9-991b-cf3085034272	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	BluePoint Laboratories	44cd6d46-fbb9-4836-9426-d8ce2cb6d66d	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Coupler LLC	2d996287-9eed-265a-e063-6294a90a6969	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f4c23037-e415-7604-e053-2995a90a5bb6	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Zydus Lifesciences Limited	4eaa8291-9cde-4205-857b-925ea8d618ba	2024-12-04		Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	6aa6bfcc-024b-4ee2-a586-6c4ca879cea4	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	69eea039-0098-4e2f-a832-152583b16f05	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b7137912-d119-4899-9c93-09c1c625f290	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	84899861-8fed-536d-e053-2991aa0a42b2	2024-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596

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	9e4e57fa-4ce3-4b7b-be5a-381801ed0386	21
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	9e4e57fa-4ce3-4b7b-be5a-381801ed0386	21
992447	promethazine HCl 25 MG Oral Tablet	PSN	a8fe4bc5-961b-4441-b8e2-ef93e4e137b6	10
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	a8fe4bc5-961b-4441-b8e2-ef93e4e137b6	10
992438	promethazine HCl 12.5 MG Oral Tablet	PSN	c0c0d4f0-8396-485b-a585-71df01491f6f	8
992447	promethazine HCl 25 MG Oral Tablet	PSN	6aa6bfcc-024b-4ee2-a586-6c4ca879cea4	8
992447	promethazine HCl 25 MG Oral Tablet	PSN	69eea039-0098-4e2f-a832-152583b16f05	8
992447	promethazine HCl 25 MG Oral Tablet	PSN	c0c0d4f0-8396-485b-a585-71df01491f6f	8
992475	promethazine HCl 50 MG Oral Tablet	PSN	c0c0d4f0-8396-485b-a585-71df01491f6f	8
992438	promethazine hydrochloride 12.5 MG Oral Tablet	SCD	c0c0d4f0-8396-485b-a585-71df01491f6f	8
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	6aa6bfcc-024b-4ee2-a586-6c4ca879cea4	8
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	69eea039-0098-4e2f-a832-152583b16f05	8
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	c0c0d4f0-8396-485b-a585-71df01491f6f	8
992475	promethazine hydrochloride 50 MG Oral Tablet	SCD	c0c0d4f0-8396-485b-a585-71df01491f6f	8
992447	promethazine HCl 25 MG Oral Tablet	PSN	bae9c9c1-107f-0fcb-e053-2a95a90a75b2	7
992447	promethazine HCl 25 MG Oral Tablet	PSN	ea490539-007b-47b1-bef9-22de02ae7c64	7
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	bae9c9c1-107f-0fcb-e053-2a95a90a75b2	7
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	ea490539-007b-47b1-bef9-22de02ae7c64	7
992447	promethazine HCl 25 MG Oral Tablet	PSN	87429921-00d2-42c7-9e99-600e8075b8ce	6
992447	promethazine HCl 25 MG Oral Tablet	PSN	84899861-8fed-536d-e053-2991aa0a42b2	6
992447	promethazine HCl 25 MG Oral Tablet	PSN	8749824b-6d66-430d-e053-2995a90a2db8	6
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	8749824b-6d66-430d-e053-2995a90a2db8	6
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	87429921-00d2-42c7-9e99-600e8075b8ce	6
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	84899861-8fed-536d-e053-2991aa0a42b2	6
992447	promethazine HCl 25 MG Oral Tablet	PSN	891a74cf-c4df-975d-e053-2a95a90a6872	5
992447	promethazine HCl 25 MG Oral Tablet	PSN	b7137912-d119-4899-9c93-09c1c625f290	5
992447	promethazine HCl 25 MG Oral Tablet	PSN	974208c8-4aad-4fb9-991b-cf3085034272	5
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	974208c8-4aad-4fb9-991b-cf3085034272	5
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	891a74cf-c4df-975d-e053-2a95a90a6872	5
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	b7137912-d119-4899-9c93-09c1c625f290	5
992447	promethazine HCl 25 MG Oral Tablet	PSN	a4fbc2d8-19b3-4556-b0b9-6e7a14cd4c36	4
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	a4fbc2d8-19b3-4556-b0b9-6e7a14cd4c36	4
992438	promethazine HCl 12.5 MG Oral Tablet	PSN	4156e780-7ecf-bcae-e063-6394a90a2ae2	2
992447	promethazine HCl 25 MG Oral Tablet	PSN	f4c23037-e415-7604-e053-2995a90a5bb6	2
992447	promethazine HCl 25 MG Oral Tablet	PSN	01b3a05f-6002-4cf9-96ac-ff0eed8a196c	2
992447	promethazine HCl 25 MG Oral Tablet	PSN	fe6294e3-2316-4efa-8be3-6e7e81158996	2
992447	promethazine HCl 25 MG Oral Tablet	PSN	4156e780-7ecf-bcae-e063-6394a90a2ae2	2
992475	promethazine HCl 50 MG Oral Tablet	PSN	4156e780-7ecf-bcae-e063-6394a90a2ae2	2
992438	promethazine hydrochloride 12.5 MG Oral Tablet	SCD	4156e780-7ecf-bcae-e063-6394a90a2ae2	2
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	01b3a05f-6002-4cf9-96ac-ff0eed8a196c	2
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	fe6294e3-2316-4efa-8be3-6e7e81158996	2
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	f4c23037-e415-7604-e053-2995a90a5bb6	2
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	4156e780-7ecf-bcae-e063-6394a90a2ae2	2
992475	promethazine hydrochloride 50 MG Oral Tablet	SCD	4156e780-7ecf-bcae-e063-6394a90a2ae2	2
992438	promethazine HCl 12.5 MG Oral Tablet	PSN	b4985d9d-1aa0-4b36-bc98-6a5410ad9bad	1
992438	promethazine HCl 12.5 MG Oral Tablet	PSN	4d30e587-6d59-4cf5-ab45-c7639f759df9	1
992447	promethazine HCl 25 MG Oral Tablet	PSN	8d952b80-84c0-409a-901f-cb26818022b8	1
992447	promethazine HCl 25 MG Oral Tablet	PSN	26ba58b7-499e-8e22-e063-6394a90a1bfa	1
992447	promethazine HCl 25 MG Oral Tablet	PSN	dcb1694a-8451-403c-b848-edb89ba17020	1
992447	promethazine HCl 25 MG Oral Tablet	PSN	4d30e587-6d59-4cf5-ab45-c7639f759df9	1
992447	promethazine HCl 25 MG Oral Tablet	PSN	b4985d9d-1aa0-4b36-bc98-6a5410ad9bad	1
992475	promethazine HCl 50 MG Oral Tablet	PSN	4d30e587-6d59-4cf5-ab45-c7639f759df9	1
992475	promethazine HCl 50 MG Oral Tablet	PSN	b4985d9d-1aa0-4b36-bc98-6a5410ad9bad	1
992438	promethazine hydrochloride 12.5 MG Oral Tablet	SCD	4d30e587-6d59-4cf5-ab45-c7639f759df9	1
992438	promethazine hydrochloride 12.5 MG Oral Tablet	SCD	b4985d9d-1aa0-4b36-bc98-6a5410ad9bad	1
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	4d30e587-6d59-4cf5-ab45-c7639f759df9	1
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	dcb1694a-8451-403c-b848-edb89ba17020	1
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	26ba58b7-499e-8e22-e063-6394a90a1bfa	1
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	b4985d9d-1aa0-4b36-bc98-6a5410ad9bad	1
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	8d952b80-84c0-409a-901f-cb26818022b8	1
992475	promethazine hydrochloride 50 MG Oral Tablet	SCD	4d30e587-6d59-4cf5-ab45-c7639f759df9	1
992475	promethazine hydrochloride 50 MG Oral Tablet	SCD	b4985d9d-1aa0-4b36-bc98-6a5410ad9bad	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-041-01	68382004101	100 TABLET in 1 BOTTLE (68382-041-01)	100 tablet	2005-12-14	0000-00-00	No	No	Current
68382-041-05	68382004105	500 TABLET in 1 BOTTLE (68382-041-05)	500 tablet	2005-12-14	0000-00-00	No	No	Current
68382-041-10	68382004110	1000 TABLET in 1 BOTTLE (68382-041-10)	1000 tablet	2005-12-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride Tablets USP	REMEDYREPACK INC.	2026-07-03	HUMAN PRESCRIPTION DRUG LABEL	22
Promethazine Hydrochloride Tablets USP	Sportpharm LLC	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	3
Promethazine Hydrochloride Tablets USP	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	2
PROMETHAZINE HYDROCHLORIDE	DIRECT RX	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	7
Promethazine Hydrochloride Tablets USP 8015401/0224 Rx only	American Health Packaging	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL	10
Promethazine Hydrochloride Tablets USP	Preferred Pharmaceuticals Inc.	2025-09-16	HUMAN PRESCRIPTION DRUG LABEL	5
Promethazine Hydrochloride Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
Promethazine Hydrochloride Tablets USP	Coupler LLC	2024-11-12	HUMAN PRESCRIPTION DRUG LABEL	1
Promethazine Hydrochloride Tablets USP	A-S Medication Solutions	2024-10-21	HUMAN PRESCRIPTION DRUG LABEL	8
Promethazine Hydrochloride Tablets USP	A-S Medication Solutions	2024-10-21	HUMAN PRESCRIPTION DRUG LABEL	8
Promethazine Hydrochloride Tablets USP	A-S Medication Solutions	2024-10-21	HUMAN PRESCRIPTION DRUG LABEL	5
Promethazine Hydrochloride Tablets USP	NuCare Pharmaceuticals,Inc.	2024-09-26	HUMAN PRESCRIPTION DRUG LABEL	6
Promethazine Hydrochloride Tablets, USP Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2024-09-13	HUMAN PRESCRIPTION DRUG LABEL	4
Promethazine Hydrochloride Tablets USP	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	7
Promethazine Hydrochloride Tablets USP	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	6
Promethazine 25mg	RedPharm Drug, Inc.	2024-06-13	HUMAN PRESCRIPTION DRUG LABEL	5
Promethazine Hydrochloride Tablets USP	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-02-26	HUMAN PRESCRIPTION DRUG LABEL	1
Promethazine Hydrochloride Tablets USP	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2023-11-07	HUMAN PRESCRIPTION DRUG LABEL	8
Promethazine Hydrochloride Tablets USP	Proficient Rx LP	2023-05-01	HUMAN PRESCRIPTION DRUG LABEL	1