Home NDC 16714-008 Isosorbide dinitrate
Product NDC 16714-008
11-digit product format 167140008
Labeler code 16714
Product ID 16714-008_be0de7ff-f8d9-472f-a35c-252a2cf16954
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isosorbide dinitrate
Dosage form TABLET
Route ORAL
Labeler Northstar Rx LLC
Application ANDA213057
Marketing category ANDA
Marketing start 2020-05-01
Substance ISOSORBIDE DINITRATE
Active strength 10 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213057-001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 2019-11-20 A213057-002 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 2019-11-20 A213057-003 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 20MG TABLET / ORAL AB 2019-11-20 A213057-004 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB 2019-11-20 A213057-005 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2019-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 5 · 190 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 A213057-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 2019-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213057-002 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 2019-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213057-003 ISOSORBIDE DINITRATE 20MG TABLET / ORAL AB 2019-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213057-004 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB 2019-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213057-005 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2019-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213057-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 2019-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213057-002 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 2019-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213057-003 ISOSORBIDE DINITRATE 20MG TABLET / ORAL AB 2019-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213057-004 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB 2019-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213057-005 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2019-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213057-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 2019-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213057-002 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 2019-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213057-003 ISOSORBIDE DINITRATE 20MG TABLET / ORAL AB 2019-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213057-004 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB 2019-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213057-005 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2019-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213057-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 2019-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213057-002 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 2019-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213057-003 ISOSORBIDE DINITRATE 20MG TABLET / ORAL AB 2019-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213057-004 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB 2019-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213057-005 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2019-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213057-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 2019-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213057-002 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 2019-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213057-003 ISOSORBIDE DINITRATE 20MG TABLET / ORAL AB 2019-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213057-004 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB 2019-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213057-005 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2019-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213057-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 2019-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213057-002 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 2019-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213057-003 ISOSORBIDE DINITRATE 20MG TABLET / ORAL AB 2019-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213057-004 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB 2019-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213057-005 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2019-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213057-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 2019-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213057-002 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 2019-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213057-003 ISOSORBIDE DINITRATE 20MG TABLET / ORAL AB 2019-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213057-004 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB 2019-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213057-005 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2019-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213057-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 2019-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213057-002 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 2019-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213057-003 ISOSORBIDE DINITRATE 20MG TABLET / ORAL AB 2019-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213057-004 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB 2019-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213057-005 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2019-11-20 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 190 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
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 10 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16714-008-01 Isosorbide dinitrate 100 in 1 BOTTLE TABLET 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-008 ISOSORBIDE DINITRATE TABLET [NORTHSTAR RX LLC] 3 Current NDC, Legacy NDC, 1 package rows 20240809_246c749d-aa28-44ce-8d42-984660afff2a.zip
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 16714-008-01 16714000801 100 TABLET in 1 BOTTLE (16714-008-01) 100 tablet 2020-05-01 0000-00-00 No No Current