Home NDC 43353-124 Hydralazine Hydrochloride
Product NDC 43353-124
11-digit product format 433530124
Labeler code 43353
Product ID 43353-124_66435209-390b-4344-9b5b-47c9c2d92e2f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydralazine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA089098
Marketing category ANDA
Marketing start 1990-09-30
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 100 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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089098-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089098-001 AA
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089098-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1985-12-18 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 100 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 905222 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 43353-124-05 Hydralazine Hydrochloride 4200 in 1 BOTTLE TABLET 4200 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-124 HYDRALAZINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20160708_d9892176-d4a6-4edb-92b9-5f56243f3d22.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 · 2 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 43353-124-05 43353012405 4200 TABLET in 1 BOTTLE (43353-124-05) 4200 tablet 2015-12-02 0000-00-00 No No Current