Home NDC 67046-1517 HYDRALAZINE HYDROCHLORIDE
Product NDC 67046-1517
11-digit product format 670461517
Labeler code 67046
Product ID 67046-1517_2df48c89-03d8-aa07-e063-6394a90acb7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydralazine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Coupler LLC
Application ANDA203845
Marketing category ANDA
Marketing start 2025-02-12
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 50 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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203845-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 A203845-002 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 A203845-003 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 129 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 2026-09-14 22:38:34 2026-08 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 2026-12-31 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 67046-1517-3 HYDRALAZINE HYDROCHLORIDE 30 in 1 BLISTER PACK TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67046-1517 HYDRALAZINE HYDROCHLORIDE TABLET [COUPLER LLC] 1 Current NDC, 1 package rows 20250215_2df51a19-a39a-0ec8-e063-6394a90a147c.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 Units Marketing start Sample Exclude flag Status 67046-1517-3 67046151703 30 TABLET in 1 BLISTER PACK (67046-1517-3) 30 tablet 2025-02-12 No No Current