Home NDC 68682-193 Isosorbide Dinitrate
Product NDC 68682-193
11-digit product format 686820193
Labeler code 68682
Product ID 68682-193_723d9f78-9d77-4575-af27-1aa117e6b8d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name isosorbide dinitrate
Dosage form TABLET
Route ORAL
Labeler Oceanside Pharmaceuticals
Application NDA012093
Marketing category NDA
Marketing start 2020-03-02
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 N012093-001 ISORDIL ISOSORBIDE DINITRATE 40MG TABLET / ORAL AB RLD, RS 1988-07-29 N012093-002 ISORDIL ISOSORBIDE DINITRATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 N012093-005 ISORDIL ISOSORBIDE DINITRATE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 N012093-006 ISORDIL ISOSORBIDE DINITRATE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 N012093-007 ISORDIL ISOSORBIDE DINITRATE 5MG TABLET / ORAL AB RLD 1988-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 6 · 210 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 N012093-001 ISORDIL 40MG TABLET / ORAL AB RLD, RS 1988-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N012093-002 ISORDIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N012093-005 ISORDIL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N012093-006 ISORDIL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N012093-007 ISORDIL 5MG TABLET / ORAL AB RLD 1988-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N012093-001 ISORDIL 40MG TABLET / ORAL AB RLD, RS 1988-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N012093-002 ISORDIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N012093-005 ISORDIL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N012093-006 ISORDIL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N012093-007 ISORDIL 5MG TABLET / ORAL AB RLD 1988-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012093-001 ISORDIL 40MG TABLET / ORAL AB RLD, RS 1988-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012093-002 ISORDIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012093-005 ISORDIL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012093-006 ISORDIL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012093-007 ISORDIL 5MG TABLET / ORAL AB RLD 1988-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N012093-001 ISORDIL 40MG TABLET / ORAL AB RLD, RS 1988-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N012093-002 ISORDIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N012093-005 ISORDIL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N012093-006 ISORDIL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N012093-007 ISORDIL 5MG TABLET / ORAL AB RLD 1988-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012093-001 ISORDIL 40MG TABLET / ORAL AB RLD, RS 1988-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012093-002 ISORDIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012093-005 ISORDIL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012093-006 ISORDIL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012093-007 ISORDIL 5MG TABLET / ORAL AB RLD 1988-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012093-001 ISORDIL 40MG TABLET / ORAL AB RLD, RS 1988-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012093-002 ISORDIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012093-005 ISORDIL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012093-006 ISORDIL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012093-007 ISORDIL 5MG TABLET / ORAL AB RLD 1988-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012093-001 ISORDIL 40MG TABLET / ORAL AB RLD, RS 1988-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012093-002 ISORDIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012093-005 ISORDIL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012093-006 ISORDIL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012093-007 ISORDIL 5MG TABLET / ORAL AB RLD 1988-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012093-001 ISORDIL 40MG TABLET / ORAL AB RLD, RS 1988-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012093-002 ISORDIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012093-005 ISORDIL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012093-006 ISORDIL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012093-007 ISORDIL 5MG TABLET / ORAL AB RLD 1988-07-29 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 81 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197840 Internal RxNorm lookup 314055 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 68682-193-01 Isosorbide Dinitrate 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-193 ISOSORBIDE DINITRATE TABLET [OCEANSIDE PHARMACEUTICALS] 1 Current NDC, Legacy NDC, 1 package rows 20200617_723d9f78-9d77-4575-af27-1aa117e6b8d7.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 68682-193-01 68682019301 100 TABLET in 1 BOTTLE (68682-193-01) 100 tablet 2020-03-02 0000-00-00 No No Current