HydrALAZINE Hydrochloride

Product NDC: 67046-2080
Requested package NDC: 67046-2080-3
11-digit product format: 670462080
Labeler code: 67046
Product ID: 67046-2080_58773dbd-7c36-7daa-e063-6394a90a6666
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HydrALAZINE Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA200770
Marketing category: ANDA
Marketing start: 2026-08-07
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
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 43.

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
A200770-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03
A200770-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03
A200770-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03
A200770-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200770-001	AA
A200770-002	AA
A200770-003	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.

Product history page 1 of 5 · 170 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
2026-09-14 22:38:34	2026-08	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 131 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A200770-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200770-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200770-003	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200770-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200770-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200770-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200770-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200770-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200770-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200770-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200770-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200770-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200770-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200770-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200770-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200770-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200770-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200770-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200770-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200770-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200770-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200770-001	AA	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: HydrALAZINE Hydrochloride
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
58773e8c-b6bc-6bc6-e063-6294a90adc26	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	58773e8c-b6bc-6bc6-e063-6294a90adc26	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200770 application number: ANDA200770 ndc (package): 67046-2080-3 ndc (product): 67046-2080 ndc11 (package): 67046208003
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Strides Pharma Science Limited	b3d1786d-c3ff-42f1-a09f-37a9c9021e5a	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200770 application number: ANDA200770
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	dfd60a79-2a30-41e6-b000-a144730099a8	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200770 application number: ANDA200770

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-2080-3	67046208003	30 TABLET in 1 BLISTER PACK (67046-2080-3)	30 tablet	2026-08-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrALAZINE HYDROCHLORIDE TABLETS, USP	Coupler LLC \| Strides Pharma Global Pte. Ltd.	2026-08-07	HUMAN PRESCRIPTION DRUG LABEL	1