Home NDC 68001-373 Isosorbide
Product NDC 68001-373
11-digit product format 680010373
Labeler code 68001
Product ID 68001-373_9498fa14-1614-4a8e-b872-41c11745b01e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isosorbide Dinitrate
Dosage form TABLET
Route ORAL
Labeler BluePoint Laboratories
Application ANDA086067
Marketing category ANDA
Marketing start 2018-11-30
Substance ISOSORBIDE DINITRATE
Active strength 5 mg/1
Pharmacologic classes 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 .
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 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A086067-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1987-10-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Isosorbide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOSORBIDE DINITRATE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IA7306519N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 206842 Internal RxNorm lookup 314055 Internal RxNorm lookup 381056 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 68001-373-00 Isosorbide 100 in 1 BOTTLE, PLASTIC TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-373 ISOSORBIDE (ISOSORBIDE DINITRATE) TABLET [BLUEPOINT LABORATORIES] 1 Current NDC, Legacy NDC, 1 package rows 20181130_9498fa14-1614-4a8e-b872-41c11745b01e.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 68001-373-00 68001037300 100 TABLET in 1 BOTTLE, PLASTIC (68001-373-00) 100 tablet 2018-11-30 0000-00-00 No No Current