HYDRALAZINE HYDROCHLORIDE

Product NDC: 23155-003
11-digit product format: 231550003
Labeler code: 23155
Product ID: 23155-003_e092716d-6522-4cfb-8728-622f9b553ef1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydralazine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA086242
Marketing category: ANDA
Marketing start: 2007-04-06
Marketing end: 2026-09-30
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag: No
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A086242-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2010-02-04
A086242-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982
A086242-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982
A086242-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2010-02-04

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 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	A086242-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086242-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-004	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086242-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086242-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086242-003	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086242-004	AA	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: HYDRALAZINE HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDRALAZINE HYDROCHLORIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FD171B778Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905199	Internal RxNorm lookup
905222	Internal RxNorm lookup
905225	Internal RxNorm lookup
905395	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
a04eefaf-ba3c-448d-8ece-4aa9ab2e3508	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a3137695-e199-b3b3-2950-87a8ac429689	Product name	5	20260316
e9ed2ee5-d109-4795-bffe-c3b047717749	Product name	2	20250107
0284f4a6-db58-dacf-18fe-da73f4aeea88	Product name	4	20180827
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
23155-003-01	HYDRALAZINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100		17
23155-003-10	HYDRALAZINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23155-003-01	EA - Each	23155-003	4f03b491-0272-408c-b20a-8ae3a81e6161	1	2012-07-24
23155-003-10	EA - Each	23155-003	4acae8a5-03d0-4acf-ab99-7ec88a803202	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]	8
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]	8
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]	8
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]	8
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]	8
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	3
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	3
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23155-003	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]	15	Current NDC, Legacy NDC, 2 package rows	20231130_a04eefaf-ba3c-448d-8ece-4aa9ab2e3508.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4671cefa-4468-4116-ba40-3d3b0f581ea1	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	db138daf-2d2d-4730-a621-a1bd209d5b9f	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	a04eefaf-ba3c-448d-8ece-4aa9ab2e3508	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242 ndc (product): 23155-003
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e9450e82-329f-4fd8-a0b3-3e8e22715965	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Northwind Health Company, LLC	ab1c6f37-3b64-23fb-e053-2995a90a932f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Northwind Health Company, LLC	ada28f78-e933-7acf-e053-2995a90ae316	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Chartwell RX, LLC	0c7f9bd0-6c0a-4521-b77a-3582faa96874	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	63f388e0-9f3d-4902-990c-9a105aa098ad	2020-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FD171B778Y	HYDRALAZINE HYDROCHLORIDE	304-20-1	HYDRALAZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	e9450e82-329f-4fd8-a0b3-3e8e22715965	22
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	e9450e82-329f-4fd8-a0b3-3e8e22715965	22
905199	hydrALAZINE HCl 10 MG Oral Tablet	PSN	a04eefaf-ba3c-448d-8ece-4aa9ab2e3508	17
905222	hydrALAZINE HCl 100 MG Oral Tablet	PSN	a04eefaf-ba3c-448d-8ece-4aa9ab2e3508	17
905225	hydrALAZINE HCl 25 MG Oral Tablet	PSN	a04eefaf-ba3c-448d-8ece-4aa9ab2e3508	17
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	a04eefaf-ba3c-448d-8ece-4aa9ab2e3508	17
905199	hydralazine hydrochloride 10 MG Oral Tablet	SCD	a04eefaf-ba3c-448d-8ece-4aa9ab2e3508	17
905222	hydralazine hydrochloride 100 MG Oral Tablet	SCD	a04eefaf-ba3c-448d-8ece-4aa9ab2e3508	17
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	a04eefaf-ba3c-448d-8ece-4aa9ab2e3508	17
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	a04eefaf-ba3c-448d-8ece-4aa9ab2e3508	17
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	9fc2bf1a-1017-4465-a333-3f974763585a	5
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	9fc2bf1a-1017-4465-a333-3f974763585a	5
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	ada28f78-e933-7acf-e053-2995a90ae316	4
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	ada28f78-e933-7acf-e053-2995a90ae316	4
905199	hydrALAZINE HCl 10 MG Oral Tablet	PSN	b44f38da-edd2-45f7-8c26-73d01ffa86b6	3
905222	hydrALAZINE HCl 100 MG Oral Tablet	PSN	b44f38da-edd2-45f7-8c26-73d01ffa86b6	3
905225	hydrALAZINE HCl 25 MG Oral Tablet	PSN	b44f38da-edd2-45f7-8c26-73d01ffa86b6	3
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	b44f38da-edd2-45f7-8c26-73d01ffa86b6	3
905199	hydralazine hydrochloride 10 MG Oral Tablet	SCD	b44f38da-edd2-45f7-8c26-73d01ffa86b6	3
905222	hydralazine hydrochloride 100 MG Oral Tablet	SCD	b44f38da-edd2-45f7-8c26-73d01ffa86b6	3
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	b44f38da-edd2-45f7-8c26-73d01ffa86b6	3
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	b44f38da-edd2-45f7-8c26-73d01ffa86b6	3
905225	hydrALAZINE HCl 25 MG Oral Tablet	PSN	5a939fe6-46b8-afcc-e053-2a91aa0a663a	2
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	5a939fe6-46b8-afcc-e053-2a91aa0a663a	2
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	5a939fe6-46b8-afcc-e053-2a91aa0a663a	2
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	5a939fe6-46b8-afcc-e053-2a91aa0a663a	2
905222	hydrALAZINE HCl 100 MG Oral Tablet	PSN	66d82f90-5f6d-41ef-b7ac-750403333e7d	1
905225	hydrALAZINE HCl 25 MG Oral Tablet	PSN	66d82f90-5f6d-41ef-b7ac-750403333e7d	1
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	66d82f90-5f6d-41ef-b7ac-750403333e7d	1
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	87c141e1-61d8-4e09-e053-2a95a90a069f	1
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	e76e3362-c892-47ab-b08c-8aee68291fe6	1
905222	hydralazine hydrochloride 100 MG Oral Tablet	SCD	66d82f90-5f6d-41ef-b7ac-750403333e7d	1
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	66d82f90-5f6d-41ef-b7ac-750403333e7d	1
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	66d82f90-5f6d-41ef-b7ac-750403333e7d	1
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	87c141e1-61d8-4e09-e053-2a95a90a069f	1
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	e76e3362-c892-47ab-b08c-8aee68291fe6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
23155-003-01	23155000301	100 TABLET, FILM COATED in 1 BOTTLE (23155-003-01)	2007-04-06	2026-09-30	No	No	Current
23155-003-10	23155000310	1000 TABLET, FILM COATED in 1 BOTTLE (23155-003-10)	2007-04-06	2026-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx only	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. \| Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	17
Rx only	PD-Rx Pharmaceuticals, Inc.	2026-01-07	HUMAN PRESCRIPTION DRUG LABEL	22
Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Rx only	REMEDYREPACK INC.	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	16
Rx only	Major Pharmaceuticals	2024-06-26	HUMAN PRESCRIPTION DRUG LABEL	9
Hydralazine Hydrochloride Tablets, USP 8073301/0422 Rx only	American Health Packaging	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	10
Rx only	Bryant Ranch Prepack	2021-12-27	HUMAN PRESCRIPTION DRUG LABEL	8
Rx only	A-S Medication Solutions	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	5
Hydralazine Hydrochloride	NuCare Pharmaceuticals, Inc.	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	3
Rx only	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-02-26	HUMAN PRESCRIPTION DRUG LABEL	1
HYDRALAZINE HYDROCHLORIDE TABLETS, USP	NuCare Pharmaceuticals, Inc.	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
HYDRALAZINE HCL	DirectRX	2019-04-30	HUMAN PRESCRIPTION DRUG LABEL	1
Hydralazine Hydrochloride	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2018-12-29	HUMAN PRESCRIPTION DRUG LABEL	2
HYDRALAZINE HYDROCHLORIDE TABLETS, USP	Aphena Pharma Solutions - Tennessee, LLC	2014-07-07	HUMAN PRESCRIPTION DRUG LABEL	1
HYDRALAZINE HYDROCHLORIDE TABLETS, USP	Aidarex Pharmaceuticals LLC	2013-10-01	HUMAN PRESCRIPTION DRUG LABEL	1
HYDRALAZINE HYDROCHLORIDE TABLETS, USP	Physicians Total Care, Inc.	2012-06-20	HUMAN PRESCRIPTION DRUG LABEL	3