Hydralazine Hydrochloride

Product NDC: 77771-182
11-digit product format: 777710182
Labeler code: 77771
Product ID: 77771-182_bd5f421e-db2b-6f83-e053-2a95a90ab05e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydralazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Radha Pharmaceuticals, Inc.
Application: ANDA205236
Marketing category: ANDA
Marketing start: 2021-03-04
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205236-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26
A205236-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26
A205236-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26
A205236-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A205236-001	AA
A205236-002	AA
A205236-003	AA
A205236-004	AA

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A205236-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205236-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205236-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205236-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A205236-001	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205236-002	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205236-003	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205236-004	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	0d65e146-83e5-427f-ac06-04c0d8e72cea	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	4aa1b3e8-9389-fe2c-e063-6294a90a7fb9	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	41c019e3-7b07-5f12-e063-6294a90a5365	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	ff2c4d1e-33ee-40d7-955b-d736f0559f39	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	8ade1ffe-3738-4aa1-b9c7-59f7290600b9	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	a8194ac4-02d5-4aa1-b4e4-a3759f6f64b5	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c2638ae6-a210-490f-8389-bbed6a3229c5	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	8224aa3d-b1b9-40df-93fd-a91c6a158898	2024-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	bc37cf50-b18d-467e-bf67-3270faa8332e	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d5b0165e-9823-470a-8ed0-5c4c8722369d	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	4d1594dc-376b-44bd-8c0e-5de731dfb7f9	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	18dd864f-1e27-4c98-8f21-eaded77a3ed6	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e6d4b15e-1407-4783-94e4-9971dea68221	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	36499d4b-bcaf-4b49-aa2a-10c3e34550d0	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	4985994c-23ab-4409-bab6-5a17db767f13	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	162a0c00-4db8-4f8d-9686-be2f8449abd8	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	914d5b62-6f9b-4665-8562-689367c36230	2023-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d4509f69-e60e-4440-957b-5c2714480335	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	62475f78-5410-43c2-a11d-54a8363c3ae1	2023-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Radha Pharmaceuticals, Inc.	149fa857-30ad-451d-b6e2-0000483ccc97	2021-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236 ndc (product): 77771-182

Additional Listing Data#

Finished product: Yes
Brand name base: Hydralazine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDRALAZINE HYDROCHLORIDE	10 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
149fa857-30ad-451d-b6e2-0000483ccc97	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
77771-182-01	Hydralazine Hydrochloride	100 in 1 BOTTLE	TABLET	100		1
77771-182-10	Hydralazine Hydrochloride	1000 in 1 BOTTLE	TABLET	1000		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
77771-182-01	EA - Each	77771-182	28767a80-48cb-481c-8b77-b070e6cc9583	1	2021-04-08
77771-182-10	EA - Each	77771-182	03e0efb3-f92b-44e1-adde-6154bd0e5745	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77771-182	HYDRALAZINE HYDROCHLORIDE TABLET [RADHA PHARMACEUTICALS, INC.]	1	Current NDC, Legacy NDC, 2 package rows	20210313_149fa857-30ad-451d-b6e2-0000483ccc97.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
905199	hydrALAZINE HCl 10 MG Oral Tablet	PSN	149fa857-30ad-451d-b6e2-0000483ccc97	1
905222	hydrALAZINE HCl 100 MG Oral Tablet	PSN	149fa857-30ad-451d-b6e2-0000483ccc97	1
905225	hydrALAZINE HCl 25 MG Oral Tablet	PSN	149fa857-30ad-451d-b6e2-0000483ccc97	1
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	149fa857-30ad-451d-b6e2-0000483ccc97	1
905199	hydralazine hydrochloride 10 MG Oral Tablet	SCD	149fa857-30ad-451d-b6e2-0000483ccc97	1
905222	hydralazine hydrochloride 100 MG Oral Tablet	SCD	149fa857-30ad-451d-b6e2-0000483ccc97	1
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	149fa857-30ad-451d-b6e2-0000483ccc97	1
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	149fa857-30ad-451d-b6e2-0000483ccc97	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77771-182-01	77771018201	100 TABLET in 1 BOTTLE (77771-182-01)	100 tablet	2021-03-04	0000-00-00	No	No	Current
77771-182-10	77771018210	1000 TABLET in 1 BOTTLE (77771-182-10)	1000 tablet	2021-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrALAZINE Hydrochloride Tablets USP	Radha Pharmaceuticals, Inc. \| ScieGen Pharmaceuticals, Inc.	2021-03-12	HUMAN PRESCRIPTION DRUG LABEL	1