Promethazine Hydrochloride

Product NDC: 65162-521
Requested package NDC: 65162-521-50
11-digit product format: 651620521
Labeler code: 65162
Product ID: 65162-521_ce7bb9fa-e802-467c-b3e3-46f92abcdce8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA091179
Marketing category: ANDA
Marketing start: 2011-03-03
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
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…`

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
05907a49-537f-4bf2-8a5f-5e905f19fece	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
65162-521-10	Promethazine Hydrochloride	100 in 1 BOTTLE	TABLET	100	19
65162-521-11	Promethazine Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	19
65162-521-50	Promethazine Hydrochloride	500 in 1 BOTTLE	TABLET	500	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-521-10	EA - Each	65162-521	536b958b-51d2-43d9-8090-ecb75e036b45	1	2012-07-24
65162-521-11	EA - Each	65162-521	dce88e6a-0c61-4d27-a4ba-a72f2cf89254	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 [PD-RX PHARMACEUTICALS, INC.]	5
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [READYMEDS]	4
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [READYMEDS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROMETHAZINE HYDROCHLORIDE TABLET [READYMEDS]	4
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PROMETHAZINE HYDROCHLORIDE TABLET [READYMEDS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [READYMEDS]	4
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS]	3
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE TABLET) TABLET [DIRECT RX]	3
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS]	3
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE TABLET) TABLET [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE TABLET) TABLET [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS]	3
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	PROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE TABLET) TABLET [DIRECT RX]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE TABLET) TABLET [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS]	3
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	1
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [APOTHECA, INC]	1
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [APOTHECA, INC]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROMETHAZINE HYDROCHLORIDE TABLET [APOTHECA, INC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PROMETHAZINE HYDROCHLORIDE TABLET [APOTHECA, INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [APOTHECA, INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-521	PROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS LLC]	19	Current NDC, Legacy NDC, 3 package rows	20241031_05907a49-537f-4bf2-8a5f-5e905f19fece.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 ndc (package): 65162-521-50 ndc (product): 65162-521 ndc11 (package): 65162052150

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
992438	promethazine HCl 12.5 MG Oral Tablet	PSN	05907a49-537f-4bf2-8a5f-5e905f19fece	19
992447	promethazine HCl 25 MG Oral Tablet	PSN	05907a49-537f-4bf2-8a5f-5e905f19fece	19
992475	promethazine HCl 50 MG Oral Tablet	PSN	05907a49-537f-4bf2-8a5f-5e905f19fece	19
992438	promethazine hydrochloride 12.5 MG Oral Tablet	SCD	05907a49-537f-4bf2-8a5f-5e905f19fece	19
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	05907a49-537f-4bf2-8a5f-5e905f19fece	19
992475	promethazine hydrochloride 50 MG Oral Tablet	SCD	05907a49-537f-4bf2-8a5f-5e905f19fece	19
992447	promethazine HCl 25 MG Oral Tablet	PSN	81fd29a9-c090-49ba-8b48-bd3656ca0c92	17
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	81fd29a9-c090-49ba-8b48-bd3656ca0c92	17
992447	promethazine HCl 25 MG Oral Tablet	PSN	3cf67ac8-05b1-465b-8e57-8640ab6f444e	7
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	3cf67ac8-05b1-465b-8e57-8640ab6f444e	7
992447	promethazine HCl 25 MG Oral Tablet	PSN	01377b4c-e5be-41b7-877f-3102b40bda91	5
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	01377b4c-e5be-41b7-877f-3102b40bda91	5
992438	promethazine HCl 12.5 MG Oral Tablet	PSN	68b620fd-6d49-4a9b-8630-7fd38611fd53	4
992447	promethazine HCl 25 MG Oral Tablet	PSN	68b620fd-6d49-4a9b-8630-7fd38611fd53	4
992438	promethazine hydrochloride 12.5 MG Oral Tablet	SCD	68b620fd-6d49-4a9b-8630-7fd38611fd53	4
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	68b620fd-6d49-4a9b-8630-7fd38611fd53	4
992447	promethazine HCl 25 MG Oral Tablet	PSN	51e3baab-eba7-460c-9de1-bf6cfc378310	3
992447	promethazine HCl 25 MG Oral Tablet	PSN	c1993112-1eeb-4b24-ac85-e623fdef3dce	3
992447	promethazine HCl 25 MG Oral Tablet	PSN	ba4ec2d8-1da4-473b-9ef8-57051cb2c0f7	3
992447	promethazine HCl 25 MG Oral Tablet	PSN	4ea41402-f085-45ac-e054-00144ff88e88	3
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	4ea41402-f085-45ac-e054-00144ff88e88	3
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	ba4ec2d8-1da4-473b-9ef8-57051cb2c0f7	3
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	c1993112-1eeb-4b24-ac85-e623fdef3dce	3
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	51e3baab-eba7-460c-9de1-bf6cfc378310	3
992447	promethazine HCl 25 MG Oral Tablet	PSN	749af379-2de0-4644-ae06-e8b03d863582	1
992447	promethazine HCl 25 MG Oral Tablet	PSN	2a9166ed-4d36-4d09-8c83-f0ccd6feeb74	1
992447	promethazine HCl 25 MG Oral Tablet	PSN	89d648db-dadc-436d-8a4d-d1637ea0e6a5	1
992447	promethazine HCl 25 MG Oral Tablet	PSN	a9075029-7a39-3b41-e053-2995a90a30a9	1
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	749af379-2de0-4644-ae06-e8b03d863582	1
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	2a9166ed-4d36-4d09-8c83-f0ccd6feeb74	1
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	89d648db-dadc-436d-8a4d-d1637ea0e6a5	1
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	a9075029-7a39-3b41-e053-2995a90a30a9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-521-50	65162052150	500 TABLET in 1 BOTTLE (65162-521-50)	500 tablet	2011-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	17
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	3
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	19
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-13	HUMAN PRESCRIPTION DRUG LABEL	3
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	REMEDYREPACK INC.	2022-05-18	HUMAN PRESCRIPTION DRUG LABEL	11
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	REMEDYREPACK INC.	2022-05-18	HUMAN PRESCRIPTION DRUG LABEL	7
Promethazine Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	Bryant Ranch Prepack	2021-12-27	HUMAN PRESCRIPTION DRUG LABEL	8
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	QPharma Inc \| Amneal Pharmaceuticals, LLC \| Denton Pharma, Inc. dba Northwind Pharmaceuticals	2021-02-19	HUMAN PRESCRIPTION DRUG LABEL	4
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	Preferred Pharmaceuticals, Inc.	2020-08-26	HUMAN PRESCRIPTION DRUG LABEL	5
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2020-06-26	HUMAN PRESCRIPTION DRUG LABEL	1
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	Unit Dose Services	2019-05-30	HUMAN PRESCRIPTION DRUG LABEL	7
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	St. Mary's Medical Park Pharmacy	2018-11-16	HUMAN PRESCRIPTION DRUG LABEL	3
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	Proficient Rx LP	2018-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	Liberty Pharmaceuticals, Inc.	2017-12-20	HUMAN PRESCRIPTION DRUG LABEL	3
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	NuCare Pharmaceuticals, Inc.	2017-08-08	HUMAN PRESCRIPTION DRUG LABEL	2
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	NuCare Pharmaceuticals, Inc.	2017-03-14	HUMAN PRESCRIPTION DRUG LABEL	1
PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only	NuCare Pharmaceuticals, Inc.	2017-02-27	HUMAN PRESCRIPTION DRUG LABEL	1
PROMETHAZINE HYDROCHLORIDE	Direct Rx	2015-06-25	HUMAN PRESCRIPTION DRUG LABEL	3
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	ReadyMeds	2014-05-06	HUMAN PRESCRIPTION DRUG LABEL	4
PROMETHAZINE HYDROCHLORIDE Tablet	Apotheca, Inc	2013-11-15	HUMAN PRESCRIPTION DRUG LABEL	1
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	Rebel Distributors Corp	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	1