HYDRALAZINE HYDROCHLORIDE

Product NDC
63629-5696
Requested package NDC
63629-5696-4
11-digit product format
636295696
Labeler code
63629
Product ID
63629-5696_1b917255-4f41-4984-bb71-5cdff4938e3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydralazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA086242
Marketing category
ANDA
Marketing start
2007-04-06
Marketing end
2026-08-31
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-569663629-5696-4IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-569663629-5696-4IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
A086242-001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE10MGTABLET / ORAL2010-02-04
A086242-002HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALApproved before 1982
A086242-003HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALApproved before 1982
A086242-004HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE100MGTABLET / ORAL2010-02-04

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 UTC2026-02A086242-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2010-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086242-002HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAAApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086242-003HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAAApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086242-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2010-02-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086242-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2010-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086242-002HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAAApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086242-003HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAAApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086242-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2010-02-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A086242-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2010-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086242-002HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAAApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086242-003HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAAApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086242-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2010-02-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086242-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2010-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086242-002HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAAApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086242-003HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAAApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086242-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2010-02-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086242-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2010-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086242-002HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAAApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086242-003HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAAApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086242-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2010-02-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086242-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2010-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086242-002HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAAApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086242-003HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAAApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086242-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2010-02-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086242-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2010-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086242-002HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAAApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086242-003HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAAApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086242-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2010-02-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086242-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2010-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086242-002HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAAApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086242-003HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAAApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086242-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2010-02-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086242-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2010-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086242-002HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAAApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086242-003HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAAApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086242-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2010-02-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086242-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2010-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A086242-002HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAAApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A086242-003HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAAApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A086242-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2010-02-04d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A086242-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086242-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086242-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086242-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086242-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086242-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086242-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086242-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A086242-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086242-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086242-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086242-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086242-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086242-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086242-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086242-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086242-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086242-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086242-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086242-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086242-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086242-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086242-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086242-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086242-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086242-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086242-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086242-004AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086242-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086242-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086242-003AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086242-004AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086242-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086242-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086242-003AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086242-004AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086242-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A086242-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A086242-003AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A086242-004AA1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
HYDRALAZINE HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE25 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
905225Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db138daf-2d2d-4730-a621-a1bd209d5b9fAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-5696-12024-05-16Rx only
63629-5696-22024-05-16Rx only
63629-5696-32024-05-16Rx only
63629-5696-42024-05-16Rx only
63629-5696-12024-01-30Rx only
63629-5696-22024-01-30Rx only
63629-5696-32024-01-30Rx only
63629-5696-42024-01-30Rx only
63629-5696-12020-10-16Rx only
63629-5696-22020-10-16Rx only
63629-5696-32020-10-16Rx only
63629-5696-12020-01-31Rx only
63629-5696-22020-01-31Rx only
63629-5696-32020-01-31Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5696-1HYDRALAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED307
63629-5696-2HYDRALAZINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED607
63629-5696-3HYDRALAZINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED907
63629-5696-4HYDRALAZINE HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED107
63629-5696-5HYDRALAZINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5696HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 5 package rows20240517_db138daf-2d2d-4730-a621-a1bd209d5b9f.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4671cefa-4468-4116-ba40-3d3b0f581ea12026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086242
application number: ANDA086242
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackdb138daf-2d2d-4730-a621-a1bd209d5b9f2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086242
application number: ANDA086242
ndc (package): 63629-5696-4
ndc (product): 63629-5696
ndc11 (package): 63629569604
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.a04eefaf-ba3c-448d-8ece-4aa9ab2e35082026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086242
application number: ANDA086242
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e9450e82-329f-4fd8-a0b3-3e8e227159652026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086242
application number: ANDA086242
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDENorthwind Health Company, LLCab1c6f37-3b64-23fb-e053-2995a90a932f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086242
application number: ANDA086242
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDENorthwind Health Company, LLCada28f78-e933-7acf-e053-2995a90ae3162026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086242
application number: ANDA086242
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEChartwell RX, LLC0c7f9bd0-6c0a-4521-b77a-3582faa968742025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086242
application number: ANDA086242
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP63f388e0-9f3d-4902-990c-9a105aa098ad2020-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086242
application number: ANDA086242

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSNdb138daf-2d2d-4730-a621-a1bd209d5b9f7
905225hydralazine hydrochloride 25 MG Oral TabletSCDdb138daf-2d2d-4730-a621-a1bd209d5b9f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-5696-46362956960410 TABLET, FILM COATED in 1 BOTTLE (63629-5696-4) 2024-04-022026-08-31NoNoCurrent