Home NDC 0228-2631 Isosorbide Mononitrate
Product NDC 0228-2631
11-digit product format 002282631
Labeler code 0228
Product ID 0228-2631_1cb05f66-1c19-4300-8745-8c74c1dccb2b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isosorbide Mononitrate
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA075037
Marketing category ANDA
Marketing start 1998-10-30
Marketing end 2027-02-28
Substance ISOSORBIDE MONONITRATE
Active strength 10 mg/1
Pharmacologic classes Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag No
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0228-2631 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 0228-2631 0228-2631-00 UNFINISHED Active or certified unfinished drug listing 2026-08-17
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 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 0228-2631-00 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 0228-2631-00 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 0228-2631-00 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 0228-2631-00 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 0228-2631-00 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 0228-2631-00 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 0228-2631-00 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 0228-2631-00 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 0228-2631-00 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 0228-2631-00 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 0228-2631-00 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 0228-2631-00 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 0228-2631-00 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 0228-2631-00 50b4072663b7…eae3003ed65e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075037-001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 A075037-002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30
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 3 · 84 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 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075037-001 ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB 1998-10-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075037-002 ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB 1998-10-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Isosorbide Mononitrate Active Ingredients# Ingredient, Strength table Ingredient Strength ISOSORBIDE MONONITRATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LX1OH63030 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311192 Internal RxNorm lookup 311197 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 0228-2631-11 Isosorbide Mononitrate 100 in 1 BOTTLE TABLET 100 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ISOSORBIDE MONONITRATE ACTIVE INGREDIENT LX1OH63030 ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] 9 ISOSORBIDE MONONITRATE ACTIVE MOIETY LX1OH63030 ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] 9 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] 9 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] 9 ISOSORBIDE MONONITRATE ACTIVE INGREDIENT LX1OH63030 ISOSORBIDE MONONITRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 ISOSORBIDE MONONITRATE ACTIVE MOIETY LX1OH63030 ISOSORBIDE MONONITRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L ISOSORBIDE MONONITRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ISOSORBIDE MONONITRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ISOSORBIDE MONONITRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ISOSORBIDE MONONITRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ISOSORBIDE MONONITRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ISOSORBIDE MONONITRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U ISOSORBIDE MONONITRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0228-2631 ISOSORBIDE MONONITRATE TABLET [ACTAVIS PHARMA, INC.] 16 Current NDC, Legacy NDC, 1 package rows 20241208_ae8f74f0-e600-4452-8557-958b603e2709.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 · 2 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 0228-2631-00 00228263100 83333 TABLET in 1 CONTAINER (0228-2631-00) 83333 tablet 07-FEB-23 Current 0228-2631-11 00228263111 100 TABLET in 1 BOTTLE (0228-2631-11) 100 tablet 1998-10-30 2027-02-28 No No Current