Home NDC 63629-9593 Isosorbide Dinitrate
Product NDC 63629-9593
11-digit product format 636299593
Labeler code 63629
Product ID 63629-9593_d39aa53f-52e2-45c6-93de-150f47e14bbf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isosorbide Dinitrate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA211290
Marketing category ANDA
Marketing start 2021-12-21
Substance ISOSORBIDE DINITRATE
Active strength 40 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 · 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 A211290-001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211290-001 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 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211290-001 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2021-11-23 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Isosorbide Dinitrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOSORBIDE DINITRATE 40 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197840 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 63629-9593-1 Isosorbide Dinitrate 100 in 1 BOTTLE TABLET 100 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-9593 ISOSORBIDE DINITRATE TABLET [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 1 package rows 20241024_73a1e6c0-71d0-4ba1-bbca-c067479e487d.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 Units Marketing start Marketing end Sample Exclude flag Status 63629-9593-1 63629959301 100 TABLET in 1 BOTTLE (63629-9593-1) 100 tablet 2021-12-21 0000-00-00 No No Current