Home NDC 50742-246 Isosorbide dinitrate and hydralazine hydrochloride
Product NDC 50742-246
11-digit product format 507420246
Labeler code 50742
Product ID 50742-246_3ba1968f-1fbf-4136-8bcd-c2af2fc93a83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isosorbide dinitrate and hydralazine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA215586
Marketing category ANDA
Marketing start 2022-04-12
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 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE 37.5MG;20MG TABLET / ORAL AB 2022-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215586-001 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.
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 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215586-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2022-04-06 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215586-001 CGT 2022-10-09 5c6f7cd8ea54…2023-01-26 05:58 UTC 2023-01 A215586-001 CGT 2022-10-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215586-001 CGT 2022-10-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215586-001 CGT 2022-10-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215586-001 CGT 2022-10-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215586-001 CGT 2022-10-09 cb3db0bc1861…
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 50742-246-18 Isosorbide dinitrate and hydralazine hydrochloride 180 in 1 BOTTLE TABLET 180 6 50742-246-90 Isosorbide dinitrate and hydralazine hydrochloride 90 in 1 BOTTLE TABLET 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-246 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE TABLET [INGENUS PHARMACEUTICALS, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20221129_8f54d5a3-169f-48dd-9250-2c176d2bd9ad.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 · 1 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 50742-246-18 50742024618 180 TABLET in 1 BOTTLE (50742-246-18) 180 tablet 2022-04-12 0000-00-00 No No Current 50742-246-90 50742024690 90 TABLET in 1 BOTTLE (50742-246-90) 90 tablet 2022-04-12 0000-00-00 No No Current