Home NDC 55154-5085 Hydralazine Hydrochloride
Product NDC 55154-5085
11-digit product format 551545085
Labeler code 55154
Product ID 55154-5085_a165dff2-f60a-4183-afe3-3adc336763a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydralazine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA088468
Marketing category ANDA
Marketing start 2011-05-13
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 1 .
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 A088468-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088468-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1984-05-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1984-05-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1984-05-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1984-05-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1984-05-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1984-05-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1984-05-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1984-05-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088468-001 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA RLD, RS 1984-05-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 55154-5085-0 Hydralazine Hydrochloride 1 in 1 BLISTER PACK TABLET 1 18 55154-5085-0 Hydralazine Hydrochloride 10 in 1 BAG TABLET 10 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-5085 HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC] 17 Current NDC, Legacy NDC, 2 package rows 20240723_db7500f3-f8a6-46b1-bb64-9727617a9643.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydralazine Hydrochloride HYDRALAZINE HYDROCHLORIDE Safecor Health, LLC 66c5eaa4-a51a-464b-98ad-f094f32876dd 2026-03-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 088468 application number: ANDA088468 Hydralazine Hydrochloride HYDRALAZINE HYDROCHLORIDE Cardinal Health 107, LLC db7500f3-f8a6-46b1-bb64-9727617a9643 2025-10-13 Warnings, Adverse reactions Exact identifier application applno (ANDA): 088468 application number: ANDA088468 ndc (product): 55154-5085 Hydralazine Hydrochloride HYDRALAZINE HYDROCHLORIDE Mylan Institutional Inc. 493a8b7e-5bb1-4db2-91a7-77ed87864131 2025-07-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 088468 application number: ANDA088468 Hydralazine Hydrochloride HYDRALAZINE HYDROCHLORIDE A-S Medication Solutions e617023e-b060-4db9-a97e-e2b11a37901e 2023-08-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 088468 application number: ANDA088468 Hydralazine Hydrochloride HYDRALAZINE HYDROCHLORIDE Teva Pharmaceuticals USA, Inc. ddbbdb09-3202-42d7-bbb0-08331dde2f54 2016-02-29 Warnings, Adverse reactions Exact identifier application applno (ANDA): 088468 application number: ANDA088468
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 55154-5085-0 55154508500 10 BLISTER PACK in 1 BAG (55154-5085-0) / 1 TABLET in 1 BLISTER PACK 10 blister pack 2011-05-13 0000-00-00 No No Current