Home NDC 63187-900 isosorbide mononitrate
Product NDC 63187-900
11-digit product format 631870900
Labeler code 63187
Product ID 63187-900_44ed966d-bf75-4379-84f4-b5270e2bb700
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name isosorbide mononitrate
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application NDA020215
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1993-06-30
Substance ISOSORBIDE MONONITRATE
Active strength 20 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020215-001 MONOKET ISOSORBIDE MONONITRATE 20MG TABLET / ORAL AB RLD, RS 1993-06-30 N020215-002 MONOKET ISOSORBIDE MONONITRATE 10MG TABLET / ORAL AB RLD 1993-06-30
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 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020215-001 MONOKET 20MG TABLET / ORAL AB RLD, RS 1993-06-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020215-002 MONOKET 10MG TABLET / ORAL AB RLD 1993-06-30 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOSORBIDE MONONITRATE 20 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 63187-900-30 isosorbide mononitrate 30 in 1 BOTTLE TABLET 30 3 63187-900-60 isosorbide mononitrate 60 in 1 BOTTLE TABLET 60 3 63187-900-90 isosorbide mononitrate 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-900 ISOSORBIDE MONONITRATE TABLET [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 3 package rows 20191108_f871dfa7-219f-4704-8e4d-215caeb7408d.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 · 5 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 63187-900-30 63187090030 30 TABLET in 1 BOTTLE (63187-900-30) 30 tablet 2017-09-01 0000-00-00 No No Current 63187-900-60 63187090060 60 TABLET in 1 BOTTLE (63187-900-60) 60 tablet 2017-09-01 0000-00-00 No No Current 63187-900-90 63187090090 90 TABLET in 1 BOTTLE (63187-900-90) 90 tablet 2017-09-01 0000-00-00 No No Current