Home NDC 43063-392 HYDRALAZINE HYDROCHLORIDE
Product NDC 43063-392
11-digit product format 430630392
Labeler code 43063
Product ID 43063-392_47d22c09-1a2d-02c7-e063-6294a90a3005
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydralazine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA086242
Marketing category ANDA
Marketing start 2007-04-06
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 50 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 44 .
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 RLD / RS Approval date A086242-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-02-04 A086242-002 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL Approved before 1982 A086242-003 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 A086242-004 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2010-02-04
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 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-02-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2010-02-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-02-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2010-02-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2010-02-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 4 · 160 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base HYDRALAZINE HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDRALAZINE HYDROCHLORIDE 50 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905395 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43063-392-90 HYDRALAZINE HYDROCHLORIDE 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDRALAZINE HYDROCHLORIDE ACTIVE INGREDIENT FD171B778Y HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 HYDRALAZINE ACTIVE MOIETY 26NAK24LS8 HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-392 HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 20 Current NDC, Legacy NDC, 1 package rows 20240507_e9450e82-329f-4fd8-a0b3-3e8e22715965.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43063-392-90 43063039290 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-392-90) 2011-03-15 0000-00-00 No No Current