Home NDC 64950-251 Isosorbide Mononitrate
Product NDC 64950-251
11-digit product format 649500251
Labeler code 64950
Product ID 64950-251_74da603c-8c7e-4823-a2a7-82e6ae007531
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isosorbide Mononitrate
Dosage form TABLET
Route ORAL
Labeler Genus Lifesciences Inc.
Application ANDA075037
Marketing category ANDA
Marketing start 2026-04-09
Substance ISOSORBIDE MONONITRATE
Active strength 20 mg/1
Pharmacologic classes Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075037-001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 A075037-002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Isosorbide Mononitrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOSORBIDE MONONITRATE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LX1OH63030 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311192 Internal RxNorm lookup 311197 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 64950-251-01 Isosorbide Mononitrate 100 in 1 BOTTLE TABLET 100 1
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 Sample Exclude flag Status 64950-251-01 64950025101 100 TABLET in 1 BOTTLE (64950-251-01) 100 tablet 2026-04-09 No No Current