PROMETHAZINE HYDROCHLORIDE

Product NDC: 10702-003
11-digit product format: 107020003
Labeler code: 10702
Product ID: 10702-003_4ceccb65-dd65-461c-e063-6294a90afcda
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: promethazine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: KVK-Tech, Inc.
Application: ANDA040712
Marketing category: ANDA
Marketing start: 2006-07-31
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A040712-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31
A040712-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04
A040712-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040712-001	AB
A040712-002	AB
A040712-003	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	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`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	A040712-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040712-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040712-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040712-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: PROMETHAZINE HYDROCHLORIDE
Listing expiration: 2027-12-31

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
7a137adf-39b7-4b14-80da-c3cac9ad562a	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
10702-003-01	2024-02-09	PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-003-10	2024-02-09	PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-003-50	2024-02-09	PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-003-01	2024-01-30	PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-003-10	2024-01-30	PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-003-50	2024-01-30	PROMETHAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10702-003-01	PROMETHAZINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100	13
10702-003-10	PROMETHAZINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET	1000	13
10702-003-50	PROMETHAZINE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10702-003-01	EA - Each	10702-003	b8596f90-204c-4a9b-b79e-93017c05ea8d	1	2013-02-13
10702-003-10	EA - Each	10702-003	e84c4693-921a-4cd4-b21e-4378aa9290f5	1	2013-02-13
10702-003-50	EA - Each	10702-003	664b0cb3-029e-40bc-949f-0476704da3e6	1	2016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	8
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	8
METHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	4GFU244C4J	PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	8
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	4
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	4
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	4
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
METHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	4GFU244C4J	PROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
METHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	4GFU244C4J	PROMETHAZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10702-003	PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	12	Current NDC, Legacy NDC, 3 package rows	20240502_7a137adf-39b7-4b14-80da-c3cac9ad562a.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6bcaa89f-5f14-dc45-e053-2a91aa0aac54	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	804e2525-d61f-7bed-e053-2991aa0a5daa	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f93ca67d-362a-473f-8296-2952da77c074	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	KVK-Tech, Inc.	7a137adf-39b7-4b14-80da-c3cac9ad562a	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 10702-003
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	d9cb1a44-d646-d9e9-e053-2995a90a24ff	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7e5715cf-056f-4095-e053-2991aa0ad3e5	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	a7b1e8b2-6f20-4096-87c7-cf349ed4f7b9	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b54439a3-1d01-4c5f-8508-731790ae215b	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b96904e7-cc67-4abc-b946-8423f3f897ff	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	2c9a4767-23c4-4a1c-bb4c-2bad1351c270	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
Promethazine	PROMETHAZINE	PharmPak, Inc.	4f681538-7ac4-484c-9e6d-b571d73b9e0b	2022-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	29a8b172-1bad-40db-8d73-1fe7fb309cff	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712

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	e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488	103
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488	103
992447	promethazine HCl 25 MG Oral Tablet	PSN	5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8	34
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8	34
992438	promethazine HCl 12.5 MG Oral Tablet	PSN	7a137adf-39b7-4b14-80da-c3cac9ad562a	13
992447	promethazine HCl 25 MG Oral Tablet	PSN	7a137adf-39b7-4b14-80da-c3cac9ad562a	13
992475	promethazine HCl 50 MG Oral Tablet	PSN	7a137adf-39b7-4b14-80da-c3cac9ad562a	13
992438	promethazine hydrochloride 12.5 MG Oral Tablet	SCD	7a137adf-39b7-4b14-80da-c3cac9ad562a	13
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	7a137adf-39b7-4b14-80da-c3cac9ad562a	13
992475	promethazine hydrochloride 50 MG Oral Tablet	SCD	7a137adf-39b7-4b14-80da-c3cac9ad562a	13
992447	promethazine HCl 25 MG Oral Tablet	PSN	2c9a4767-23c4-4a1c-bb4c-2bad1351c270	10
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	2c9a4767-23c4-4a1c-bb4c-2bad1351c270	10
992438	promethazine HCl 12.5 MG Oral Tablet	PSN	857dd0a8-3e23-423c-9b5e-9a8779b4c7d0	9
992447	promethazine HCl 25 MG Oral Tablet	PSN	857dd0a8-3e23-423c-9b5e-9a8779b4c7d0	9
992438	promethazine hydrochloride 12.5 MG Oral Tablet	SCD	857dd0a8-3e23-423c-9b5e-9a8779b4c7d0	9
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	857dd0a8-3e23-423c-9b5e-9a8779b4c7d0	9
992447	promethazine HCl 25 MG Oral Tablet	PSN	40d4ef22-f12f-0667-e054-00144ff8d46c	6
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	40d4ef22-f12f-0667-e054-00144ff8d46c	6
992447	promethazine HCl 25 MG Oral Tablet	PSN	29a8b172-1bad-40db-8d73-1fe7fb309cff	5
992447	promethazine HCl 25 MG Oral Tablet	PSN	b96904e7-cc67-4abc-b946-8423f3f897ff	5
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	29a8b172-1bad-40db-8d73-1fe7fb309cff	5
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	b96904e7-cc67-4abc-b946-8423f3f897ff	5
992447	promethazine HCl 25 MG Oral Tablet	PSN	804e2525-d61f-7bed-e053-2991aa0a5daa	4
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	804e2525-d61f-7bed-e053-2991aa0a5daa	4
992447	promethazine HCl 25 MG Oral Tablet	PSN	a7b1e8b2-6f20-4096-87c7-cf349ed4f7b9	3
992447	promethazine HCl 25 MG Oral Tablet	PSN	d9cb1a44-d646-d9e9-e053-2995a90a24ff	3
992447	promethazine HCl 25 MG Oral Tablet	PSN	c8b6d06b-1468-4ff5-bf76-813abb5a093f	3
992447	promethazine HCl 25 MG Oral Tablet	PSN	b54439a3-1d01-4c5f-8508-731790ae215b	3
992447	promethazine HCl 25 MG Oral Tablet	PSN	7e5715cf-056f-4095-e053-2991aa0ad3e5	3
992447	promethazine HCl 25 MG Oral Tablet	PSN	6bcaa89f-5f14-dc45-e053-2a91aa0aac54	3
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	a7b1e8b2-6f20-4096-87c7-cf349ed4f7b9	3
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	b54439a3-1d01-4c5f-8508-731790ae215b	3
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	6bcaa89f-5f14-dc45-e053-2a91aa0aac54	3
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	c8b6d06b-1468-4ff5-bf76-813abb5a093f	3
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	d9cb1a44-d646-d9e9-e053-2995a90a24ff	3
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	7e5715cf-056f-4095-e053-2991aa0ad3e5	3
992447	promethazine HCl 25 MG Oral Tablet	PSN	96b4ab0d-abcf-409a-872e-b69611ebecca	2
992447	promethazine HCl 25 MG Oral Tablet	PSN	4f681538-7ac4-484c-9e6d-b571d73b9e0b	2
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	96b4ab0d-abcf-409a-872e-b69611ebecca	2
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	4f681538-7ac4-484c-9e6d-b571d73b9e0b	2
992447	promethazine HCl 25 MG Oral Tablet	PSN	7df0a51f-ea74-754b-e053-2991aa0a5e6c	1
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	7df0a51f-ea74-754b-e053-2991aa0a5e6c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10702-003-01	10702000301	100 TABLET in 1 BOTTLE (10702-003-01)	100 tablet	2006-07-31	0000-00-00	No	No	Current
10702-003-10	10702000310	1000 TABLET in 1 BOTTLE (10702-003-10)	1000 tablet	2006-07-31	0000-00-00	No	No	Current
10702-003-50	10702000350	500 TABLET in 1 BOTTLE (10702-003-50)	500 tablet	2016-05-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	NuCare Pharmaceuticals,Inc.	2026-07-30	HUMAN PRESCRIPTION DRUG LABEL	4
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	NuCare Pharmaceuticals,Inc.	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	5
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	Bryant Ranch Prepack	2026-06-05	HUMAN PRESCRIPTION DRUG LABEL	104
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	PD-Rx Pharmaceuticals, Inc.	2026-05-22	HUMAN PRESCRIPTION DRUG LABEL	34
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	KVK-Tech, Inc.	2026-03-13	HUMAN PRESCRIPTION DRUG LABEL	13
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	Quality Care Products LLC	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL	11
PROMETHAZINE HYDROCHLORIDE - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-02	HUMAN PRESCRIPTION DRUG LABEL	6
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	NuCare Pharmaceuticals,Inc.	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	3
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	A-S Medication Solutions	2023-12-15	HUMAN PRESCRIPTION DRUG LABEL	3
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	A-S Medication Solutions	2023-12-15	HUMAN PRESCRIPTION DRUG LABEL	3
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	A-S Medication Solutions	2023-10-24	HUMAN PRESCRIPTION DRUG LABEL	5
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	A-S Medication Solutions	2023-05-08	HUMAN PRESCRIPTION DRUG LABEL	10
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	REMEDYREPACK INC.	2023-02-07	HUMAN PRESCRIPTION DRUG LABEL	7
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	5
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	Golden State Medical Supply, Inc.	2022-12-02	HUMAN PRESCRIPTION DRUG LABEL	9
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	PharmPak, Inc.	2022-10-08	HUMAN PRESCRIPTION DRUG LABEL	2
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	5
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	Bryant Ranch Prepack	2021-12-23	HUMAN PRESCRIPTION DRUG LABEL	4