Home NDC 16714-007 Isosorbide dinitrate
Product NDC 16714-007
11-digit product format 167140007
Labeler code 16714
Product ID 16714-007_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 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 · source snapshot 42 .
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 · 195 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 A213057-001 ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213057-002 ISOSORBIDE DINITRATE 10MG TABLET / ORAL AB 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213057-003 ISOSORBIDE DINITRATE 20MG TABLET / ORAL AB 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213057-004 ISOSORBIDE DINITRATE 30MG TABLET / ORAL AB 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213057-005 ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB 2019-11-20 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 195 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 · 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 16714-007-01 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 16714-007 ISOSORBIDE DINITRATE TABLET [NORTHSTAR RX LLC] 3 Current NDC, Legacy NDC, 1 package rows 20240809_246c749d-aa28-44ce-8d42-984660afff2a.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 · 4 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 16714-007-01 16714000701 100 TABLET in 1 BOTTLE (16714-007-01) 100 tablet 2020-05-01 0000-00-00 No No Current