Home NDC 49884-009 Isosorbide Dinitrate
Product NDC 49884-009
11-digit product format 498840009
Labeler code 49884
Product ID 49884-009_bb122d4c-8b22-44dd-9c60-772123f18a4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name isosorbide dinitrate
Dosage form TABLET
Route ORAL
Labeler Endo USA, Inc.
Application ANDA087946
Marketing category ANDA
Marketing start 1983-02-10
Substance ISOSORBIDE DINITRATE
Active strength 30 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 42 .
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 A087946-001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087946-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087946-001 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB RS 1988-01-12 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Isosorbide Dinitrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOSORBIDE DINITRATE 30 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197839 Internal RxNorm lookup 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 49884-009-01 2022-08-19 ISOSORBIDE DINITRATE TABLETS, USP Rx only 49884-009-01 2022-08-19 ISOSORBIDE DINITRATE TABLETS, USP Rx only 49884-009-10 2022-08-19 ISOSORBIDE DINITRATE TABLETS, USP Rx only 49884-009-10 2022-08-19 ISOSORBIDE DINITRATE TABLETS, USP Rx only 49884-009-01 2022-07-29 ISOSORBIDE DINITRATE TABLETS, USP Rx only 49884-009-01 2022-07-29 ISOSORBIDE DINITRATE TABLETS, USP Rx only 49884-009-10 2022-07-29 ISOSORBIDE DINITRATE TABLETS, USP Rx only 49884-009-10 2022-07-29 ISOSORBIDE DINITRATE TABLETS, USP Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49884-009-01 Isosorbide Dinitrate 100 in 1 BOTTLE TABLET 100 17 49884-009-10 Isosorbide Dinitrate 1000 in 1 BOTTLE TABLET 1000 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-009 ISOSORBIDE DINITRATE TABLET [ENDO USA, INC.] 17 Current NDC, Legacy NDC, 2 package rows 20240926_6df6a2fa-c56c-4eb6-a485-c16585420eb0.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 49884-009-01 49884000901 100 TABLET in 1 BOTTLE (49884-009-01) 100 tablet 1983-02-10 0000-00-00 No No Current 49884-009-10 49884000910 1000 TABLET in 1 BOTTLE (49884-009-10) 1000 tablet 1983-02-10 0000-00-00 No No Current