Hydralazine Hydrochloride

Product NDC: 68462-342
11-digit product format: 684620342
Labeler code: 68462
Product ID: 68462-342_617acbb5-012a-416f-bf6c-fd766a25711c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydralazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA090527
Marketing category: ANDA
Marketing start: 2009-05-29
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 25 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 42.

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
A090527-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29
A090527-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29
A090527-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29
A090527-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090527-001	AA
A090527-002	AA
A090527-003	AA
A090527-004	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.

Product history page 1 of 5 · 168 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
2026-08-18 06:07:40	2026-07	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090527-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-003	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-004	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090527-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090527-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-004	AA	1	`d8e5a09893c0…`

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	25 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
37ba0233-ed75-498a-a067-6220da573653	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
0284f4a6-db58-dacf-18fe-da73f4aeea88	Product name	4	20180827
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68462-342-01	Hydralazine Hydrochloride	100 in 1 BOTTLE	TABLET	100	9
68462-342-05	Hydralazine Hydrochloride	500 in 1 BOTTLE	TABLET	500	9
68462-342-10	Hydralazine Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-342-01	EA - Each	68462-342	4ef696ab-c920-4c0f-b0e8-8d67337ae5e4	1	2012-07-24
68462-342-05	EA - Each	68462-342	debaf187-07f1-4463-ade0-25d25f3b5944	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 [GLENMARK PHARMACEUTICALS INC., USA]	5
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-342	HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	9	Current NDC, Legacy NDC, 3 package rows	20241207_37ba0233-ed75-498a-a067-6220da573653.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	37ba0233-ed75-498a-a067-6220da573653	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090527 application number: ANDA090527 ndc (product): 68462-342

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	37ba0233-ed75-498a-a067-6220da573653	9
905222	hydrALAZINE HCl 100 MG Oral Tablet	PSN	37ba0233-ed75-498a-a067-6220da573653	9
905225	hydrALAZINE HCl 25 MG Oral Tablet	PSN	37ba0233-ed75-498a-a067-6220da573653	9
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	37ba0233-ed75-498a-a067-6220da573653	9
905199	hydralazine hydrochloride 10 MG Oral Tablet	SCD	37ba0233-ed75-498a-a067-6220da573653	9
905222	hydralazine hydrochloride 100 MG Oral Tablet	SCD	37ba0233-ed75-498a-a067-6220da573653	9
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	37ba0233-ed75-498a-a067-6220da573653	9
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	37ba0233-ed75-498a-a067-6220da573653	9
905225	hydrALAZINE HCl 25 MG Oral Tablet	PSN	e655d43f-c63d-49cd-9a3d-14dde2045e8b	6
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	e655d43f-c63d-49cd-9a3d-14dde2045e8b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68462-342-01	68462034201	100 TABLET in 1 BOTTLE (68462-342-01)	100 tablet	2009-05-29	No	No	Current
68462-342-05	68462034205	500 TABLET in 1 BOTTLE (68462-342-05)	500 tablet	2009-05-29	No	No	Current
68462-342-10	68462034210	1000 TABLET in 1 BOTTLE (68462-342-10)	1000 tablet	2009-05-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydralazine Hydrochloride Tablets, USP	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2024-05-24	HUMAN PRESCRIPTION DRUG LABEL	9
Hydralazine Hydrochloride Tablets USP	A-S Medication Solutions	2017-08-30	HUMAN PRESCRIPTION DRUG LABEL	6