Hydralazine Hydrochloride

Product NDC
50436-4034
11-digit product format
504364034
Labeler code
50436
Product ID
50436-4034_5b9fd3c0-d4da-4d35-a3bd-8d01cad614bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA086242
Marketing category
ANDA
Marketing start
2007-04-06
Marketing end
0000-00-00
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-4034DDiscontinued by firm2026-08-10
excluded packagepackage50436-403450436-4034-1DDiscontinued by firm2026-08-10

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-4034-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-4034-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-4034-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-4034-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-4034-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-4034-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-4034-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-4034-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-4034-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-4034-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-4034-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-4034-1557ba5c1ecfa…9c80585c8c6e…

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…

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
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