Home NDC 72319-012 isosorbide dinitrate and hydralazine hydrochloride
Product NDC 72319-012
11-digit product format 723190012
Labeler code 72319
Product ID 72319-012_1898d58a-a951-f2a3-e063-6394a90a5e9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name isosorbide dinitrate and hydralazine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler i3 Pharmaceuticals, LLC
Application ANDA215988
Marketing category ANDA
Marketing start 2024-02-07
Substance ISOSORBIDE DINITRATE; HYDRALAZINE HYDROCHLORIDE
Active strength 20; 37.5 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 43 .
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 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE 37.5MG;20MG TABLET / ORAL AB 2024-01-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215988-001 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 2026-09-14 22:38:34 2026-08 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215988-001 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 37.5MG;20MG TABLET / ORAL AB 2024-01-17 a50c72e98297…
Observed Orange Book normalized TE history# 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 isosorbide dinitrate and hydralazine hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOSORBIDE DINITRATE 20 mg/1 HYDRALAZINE HYDROCHLORIDE 37.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IA7306519N Internal UNII lookup 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 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 72319-012-03 isosorbide dinitrate and hydralazine hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 7 72319-012-18 isosorbide dinitrate and hydralazine hydrochloride 180 in 1 BOTTLE TABLET, FILM COATED 180 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72319-012 ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [I3 PHARMACEUTICALS, LLC] 7 Current NDC, 2 package rows 20240529_cacf1a7c-0388-09ee-e053-2995a90a10cf.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 Marketing start Sample Exclude flag Status 72319-012-03 72319001203 90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03) 2024-02-07 No No Current 72319-012-18 72319001218 180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18) 2024-02-07 No No Current