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

Additional Listing Data#

Finished product: Yes
Brand name base: HYDRALAZINE HYDROCHLORIDE

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	FD171B778Y
Rxcui	905199, 905222, 905225, 905395

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	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	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, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	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 [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 [AIDAREX PHARMACEUTICALS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	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
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, 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 [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	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
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	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
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS 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

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	A-S Medication Solutions	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	5
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

HYDRALAZINE HYDROCHLORIDE

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#