HydrALAZINE Hydrochloride

Product NDC: 64380-733
Requested package NDC: 64380-733-06
11-digit product format: 643800733
Labeler code: 64380
Product ID: 64380-733_198e8715-f4c9-4b66-9e8e-61edab911f51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HydrALAZINE Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA200770
Marketing category: ANDA
Marketing start: 2022-06-30
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 10 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 44.

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 · 174 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
2026-10-15 13:18:30	2026-09	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 134 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A200770-001	AA	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200770-002	AA	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200770-003	AA	1	`c2088c7a36db…`
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…`

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	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
b3d1786d-c3ff-42f1-a09f-37a9c9021e5a	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	SPL version
64380-733-06	HydrALAZINE Hydrochloride	100 in 1 BOTTLE	TABLET	100	12
64380-733-07	HydrALAZINE Hydrochloride	500 in 1 BOTTLE	TABLET	500	12
64380-733-08	HydrALAZINE Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]	6
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]	6
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-733	HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]	12	Current NDC, Legacy NDC, 3 package rows	20220701_b3d1786d-c3ff-42f1-a09f-37a9c9021e5a.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 · 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
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 ndc (package): 64380-733-06 ndc (product): 64380-733 ndc11 (package): 64380073306
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	Marketing end	Sample	Exclude flag	Status
64380-733-06	64380073306	100 TABLET in 1 BOTTLE (64380-733-06)	100 tablet	2022-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrALAZINE HYDROCHLORIDE TABLETS, USP	Strides Pharma Science Limited \| Strides Pharma Global Pte. Ltd.	2026-02-02	HUMAN PRESCRIPTION DRUG LABEL	13