FDA.reportPublic FDA data

NDC 16729-398-01 - isosorbide mononitrate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
16729-398
Requested NDC
16729-398-01
Package NDCs from labels
16729-398-15, 16729-398-01, 16729-398-16, 16729-398-17
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2023-02-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
isosorbide mononitrate - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2023-02-01HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
16729-398-012023-02-01Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-398-152023-02-01Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-398-162023-02-01Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-398-172023-02-01Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-398-012023-01-30Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-398-152023-01-30Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-398-162023-01-30Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-398-172023-01-30Isosorbide Mononitrate Extended-Release Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-398-01isosorbide mononitrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
16729-398-15isosorbide mononitrate90 in 1 BOTTLETABLET, EXTENDED RELEASE904
16729-398-16isosorbide mononitrate500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
16729-398-17isosorbide mononitrate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-398ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE INC.]44 package rows20250101_cd439861-2e23-4e0e-bcdc-48e2ebdc4943.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 32 of 32 · 622 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ThyrotoxCHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.e229a260-13f3-4136-b325-9a8954f8a3272016-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
TeethingARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEABioActive Nutritional, Inc.f39c9feb-f567-43a2-a026-2a581aeeed9d2016-07-27WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.