Home NDC 71209-016 HYDRALAZINE HYDROCHLORIDE
Product NDC 71209-016
11-digit product format 712090016
Labeler code 71209
Product ID 71209-016_4cdbf75c-b17f-4c40-bd7c-7b07668e9659
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydralazine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Cadila Pharmaceuticals Limited
Application ANDA203845
Marketing category ANDA
Marketing start 2015-12-29
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 25 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 25 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905222 Internal RxNorm lookup 905225 Internal RxNorm lookup 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 71209-016-05 HYDRALAZINE HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 6 71209-016-11 HYDRALAZINE HYDROCHLORIDE 1000 in 1 BOTTLE TABLET 1000 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71209-016 HYDRALAZINE HYDROCHLORIDE TABLET [CADILA PHARMACEUTICALS LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20221230_3a7562a8-2f67-4411-ac4a-ab7924193e82.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 Marketing end Sample Exclude flag Status 71209-016-05 71209001605 100 TABLET in 1 BOTTLE (71209-016-05) 100 tablet 2015-12-29 0000-00-00 No No Current 71209-016-11 71209001611 1000 TABLET in 1 BOTTLE (71209-016-11) 1000 tablet 2015-12-29 0000-00-00 No No Current