Hydralazine Hydrochloride

Product NDC
0615-7973
11-digit product format
006157973
Labeler code
0615
Product ID
0615-7973_502998b4-a486-4c38-ae3a-a47512d2c58c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA040901
Marketing category
ANDA
Marketing start
2010-01-01
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
100 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040901-001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2008-09-12
A040901-002HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2008-09-12
A040901-003HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2008-09-12
A040901-004HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2008-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040901-001AA
A040901-002AA
A040901-003AA
A040901-004AA

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040901-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2008-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040901-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2008-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040901-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2008-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040901-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2008-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040901-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2008-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040901-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2008-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040901-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2008-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040901-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2008-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040901-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2008-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040901-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2008-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040901-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2008-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040901-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2008-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040901-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2008-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040901-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2008-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040901-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2008-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040901-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2008-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040901-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2008-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040901-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2008-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040901-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2008-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040901-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2008-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040901-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2008-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040901-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2008-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040901-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2008-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040901-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2008-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040901-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2008-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040901-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2008-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040901-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2008-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040901-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2008-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040901-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2008-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040901-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2008-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040901-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2008-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040901-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2008-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040901-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2008-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040901-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2008-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040901-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2008-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040901-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2008-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040901-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2008-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A040901-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2008-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A040901-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2008-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A040901-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2008-09-12d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040901-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040901-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040901-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040901-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040901-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040901-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040901-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040901-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040901-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040901-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040901-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040901-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040901-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040901-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040901-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040901-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040901-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040901-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040901-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040901-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040901-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040901-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040901-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040901-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040901-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040901-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040901-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040901-004AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040901-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040901-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040901-003AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040901-004AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040901-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040901-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040901-003AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040901-004AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040901-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040901-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040901-003AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040901-004AA1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FD171B778YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
905222Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f07abdec-6d94-45b6-be1b-10a898ea28c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3137695-e199-b3b3-2950-87a8ac429689Product name520260316
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-7973-05Hydralazine Hydrochloride15 in 1 BLISTER PACKTABLET156
0615-7973-39Hydralazine Hydrochloride30 in 1 BLISTER PACKTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-7973HYDRALAZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]6Current NDC, Legacy NDC, 2 package rows20240814_f07abdec-6d94-45b6-be1b-10a898ea28c2.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.438479d0-ff61-4008-a0fc-1ee44b97cf7f2026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.89afc8ef-27c4-489a-81de-3f8f65f6bbb82026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutions7253aaa0-e272-499f-9bfa-304e9556a8fb2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutionsf16f1d87-f9e6-4555-9baf-26ff17cb1d282025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackd2d98842-ff32-4a61-94e0-60e06919948f2025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepacka79ddc89-546b-4808-879d-c0f5921416362025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack90c18c55-3045-4a10-a2bb-012e4a5e15642025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECamber Pharmaceuticals, Inc.5da36930-d3da-4b5c-9e22-2b141bc01a9c2025-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP775e99c4-e18d-4648-a0e3-8709950249ff2025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a862321d-ebc1-7676-e053-2995a90a58612024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsf07abdec-6d94-45b6-be1b-10a898ea28c22024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
ndc (product): 0615-7973
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.3b61d1b0-c699-67a8-e054-00144ff88e882024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4b7d3378-86f8-0a5f-e054-00144ff8d46c2024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP48cf71dd-19dc-4239-9117-ebcf9731a45d2019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040901
application number: ANDA040901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905222hydrALAZINE HCl 100 MG Oral TabletPSNf07abdec-6d94-45b6-be1b-10a898ea28c26
905222hydralazine hydrochloride 100 MG Oral TabletSCDf07abdec-6d94-45b6-be1b-10a898ea28c26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-7973-050061579730515 TABLET in 1 BLISTER PACK (0615-7973-05) 15 tablet2022-11-100000-00-00NoNoCurrent
0615-7973-390061579733930 TABLET in 1 BLISTER PACK (0615-7973-39) 30 tablet2010-01-010000-00-00NoNoCurrent