Home NDC 52536-006 isosorbide dinitrate and hydralazine hydrochloride
Product NDC 52536-006
11-digit product format 525360006
Labeler code 52536
Product ID 52536-006_13386839-9eb4-4956-a788-d94a7b63cb77
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydralazine hydrochloride and isosorbide dinitrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wilshire Pharmaceuticals
Application NDA020727
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-04-15
Substance HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Active strength 37.5; 20 mg/1; mg/1
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
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 N020727-001 BIDIL HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020727-001 AB
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 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Additional Listing Data#
Finished product Yes
Brand name base isosorbide dinitrate and hydralazine hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDRALAZINE HYDROCHLORIDE 37.5 mg/1 ISOSORBIDE DINITRATE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FD171B778Y Internal UNII lookup IA7306519N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905377 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 52536-006-09 isosorbide dinitrate and hydralazine hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52536-006 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [WILSHIRE PHARMACEUTICALS] 2 Current NDC, Legacy NDC, 1 package rows 20220416_620a0680-aad0-4923-84be-7393c0cbdcbd.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 52536-006-09 52536000609 90 TABLET, FILM COATED in 1 BOTTLE (52536-006-09) 2022-04-15 0000-00-00 No No Current