Hydralazine Hydrochloride

Product NDC
67046-1660
Requested package NDC
67046-1660-3
11-digit product format
670461660
Labeler code
67046
Product ID
67046-1660_4aa1b35f-6678-9062-e063-6394a90acbee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA205236
Marketing category
ANDA
Marketing start
2026-02-12
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
25 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 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
A205236-001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2017-05-26
A205236-002HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2017-05-26
A205236-003HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2017-05-26
A205236-004HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2017-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205236-001AA
A205236-002AA
A205236-003AA
A205236-004AA

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 UTC2026-02A205236-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2017-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205236-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2017-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205236-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2017-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205236-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2017-05-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205236-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2017-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205236-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2017-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205236-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2017-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205236-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2017-05-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A205236-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2017-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205236-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2017-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205236-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2017-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205236-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2017-05-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205236-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2017-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205236-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2017-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205236-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2017-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205236-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2017-05-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205236-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2017-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205236-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2017-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205236-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2017-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205236-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2017-05-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205236-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2017-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205236-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2017-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205236-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2017-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205236-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2017-05-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205236-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2017-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205236-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2017-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205236-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2017-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205236-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2017-05-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205236-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2017-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205236-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2017-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205236-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2017-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205236-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2017-05-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205236-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2017-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205236-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2017-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205236-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2017-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205236-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2017-05-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205236-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2017-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A205236-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2017-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A205236-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2017-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A205236-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2017-05-26d06236e962d9…

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 UTC2026-02A205236-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205236-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205236-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205236-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205236-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205236-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205236-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205236-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205236-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205236-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205236-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205236-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205236-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205236-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205236-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205236-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205236-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205236-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205236-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205236-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205236-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205236-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205236-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205236-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205236-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205236-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205236-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205236-004AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205236-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205236-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205236-003AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205236-004AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205236-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205236-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205236-003AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205236-004AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205236-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205236-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205236-003AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205236-004AA1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydralazine Hydrochloride
Listing expiration
2027-12-31

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
4aa1b3e8-9389-fe2c-e063-6294a90a7fb9Available 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
67046-1660-3Hydralazine Hydrochloride30 in 1 BLISTER PACKTABLET301

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.0d65e146-83e5-427f-ac06-04c0d8e72cea2026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC4aa1b3e8-9389-fe2c-e063-6294a90a7fb92026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
ndc (package): 67046-1660-3
ndc (product): 67046-1660
ndc11 (package): 67046166003
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC41c019e3-7b07-5f12-e063-6294a90a53652025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackff2c4d1e-33ee-40d7-955b-d736f0559f392024-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutions8ade1ffe-3738-4aa1-b9c7-59f7290600b92024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutionsa8194ac4-02d5-4aa1-b4e4-a3759f6f64b52024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc2638ae6-a210-490f-8389-bbed6a3229c52024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack8224aa3d-b1b9-40df-93fd-a91c6a1588982024-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackbc37cf50-b18d-467e-bf67-3270faa8332e2024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackd5b0165e-9823-470a-8ed0-5c4c8722369d2024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack4d1594dc-376b-44bd-8c0e-5de731dfb7f92024-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack18dd864f-1e27-4c98-8f21-eaded77a3ed62024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepacke6d4b15e-1407-4783-94e4-9971dea682212024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack36499d4b-bcaf-4b49-aa2a-10c3e34550d02024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack4985994c-23ab-4409-bab6-5a17db767f132024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack162a0c00-4db8-4f8d-9686-be2f8449abd82024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack914d5b62-6f9b-4665-8562-689367c362302023-12-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackd4509f69-e60e-4440-957b-5c27144803352023-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack62475f78-5410-43c2-a11d-54a8363c3ae12023-07-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDERadha Pharmaceuticals, Inc.149fa857-30ad-451d-b6e2-0000483ccc972021-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205236
application number: ANDA205236

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSN4aa1b3e8-9389-fe2c-e063-6294a90a7fb91
905225hydralazine hydrochloride 25 MG Oral TabletSCD4aa1b3e8-9389-fe2c-e063-6294a90a7fb91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1660-36704616600330 TABLET in 1 BLISTER PACK (67046-1660-3) 30 tablet2026-02-12NoNoCurrent