Home NDC 0781-1635 Isosorbide Dinitrate
Product NDC 0781-1635
11-digit product format 007811635
Labeler code 0781
Product ID 0781-1635_9c848a4f-2720-4c80-a0be-e49200cb10f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isosorbide Dinitrate
Dosage form TABLET
Route ORAL
Labeler Sandoz Inc.
Application ANDA086221
Marketing category ANDA
Marketing start 1988-01-07
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A086221-001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A086221-001 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.
Product history page 1 of 2 · 41 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 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A086221-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 1988-01-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0781-1635-01 2022-08-09 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-01 2022-08-09 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-10 2022-08-09 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-10 2022-08-09 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-13 2022-08-09 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-13 2022-08-09 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-01 2022-07-29 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-01 2022-07-29 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-10 2022-07-29 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-10 2022-07-29 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-13 2022-07-29 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-13 2022-07-29 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-01 2020-08-03 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-01 2020-08-03 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-10 2020-08-03 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-10 2020-08-03 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-13 2020-08-03 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-13 2020-08-03 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-01 2020-07-22 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-01 2020-07-22 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-10 2020-07-22 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-10 2020-07-22 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-13 2020-07-22 Isosorbide Dinitrate Tablets, USP (Oral) 0781-1635-13 2020-07-22 Isosorbide Dinitrate Tablets, USP (Oral)
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-1635-01 Isosorbide Dinitrate 100 in 1 BOTTLE TABLET 100 19 0781-1635-10 Isosorbide Dinitrate 1000 in 1 BOTTLE TABLET 1000 19 0781-1635-13 Isosorbide Dinitrate 10 in 1 CARTON TABLET 10 19 0781-1635-13 Isosorbide Dinitrate 10 in 1 BLISTER PACK TABLET 10 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-1635 ISOSORBIDE DINITRATE TABLET [SANDOZ INC.] 18 Current NDC, Legacy NDC, 4 package rows 20240504_71fdd147-a987-40b6-9f07-82d56525ceb8.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 0781-1635-01 00781163501 100 TABLET in 1 BOTTLE (0781-1635-01) 100 tablet 1988-01-07 0000-00-00 No No Current 0781-1635-10 00781163510 1000 TABLET in 1 BOTTLE (0781-1635-10) 1000 tablet 1988-01-07 0000-00-00 No No Current 0781-1635-13 00781163513 10 in 1 CARTON Historical