FDA.reportPublic FDA data

NDC 16729-397 - 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
16729-397
Package NDCs from labels
16729-397-15, 16729-397-01, 16729-397-16, 16729-397-17
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
16729-397-012023-02-01Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-152023-02-01Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-162023-02-01Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-172023-02-01Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-012023-01-30Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-152023-01-30Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-162023-01-30Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-172023-01-30Isosorbide Mononitrate Extended-Release Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-397-01isosorbide mononitrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
16729-397-15isosorbide mononitrate90 in 1 BOTTLETABLET, EXTENDED RELEASE904
16729-397-16isosorbide mononitrate500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
16729-397-17isosorbide mononitrate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-397ISOSORBIDE 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 29 of 33 · 643 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SiliceaSILICEAHahnemann Laboratories, INC.efcdc393-5dab-38d1-e053-2995a90acb2e2022-12-14Exact identifier
unii: ETJ7Z6XBU4
Defend Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.bb851be1-0528-4199-91e7-e09f994b28622022-12-12WarningsExact identifier
unii: ETJ7Z6XBU4
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic CombinationCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAOHM PHARMA INC.044a7174-f7a3-490f-9cad-01f2665d75752022-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATEAurobindo Pharma Limited55810c9d-1140-40b8-a297-210a84afc05a2022-11-11Warnings, Adverse reactionsExact identifier
rxcui: 317110
rxcui: 311196
rxcui: 353538
unii: LX1OH63030
Isosorbide MononitrateISOSORBIDE MONONITRATEActavis Pharma, Inc.ae8f74f0-e600-4452-8557-958b603e27092022-10-01Warnings, Adverse reactionsExact identifier
unii: LX1OH63030
Hendel Periodontal and Tooth Pain ReliefSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDEMediNatura Incf34e9f77-69fd-4c7f-9eea-2d721a4d27fb2022-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe Mexico, S.A. de C.V.3e2e5f52-db54-4635-83a8-a67a683c093c2022-03-22WarningsExact identifier
unii: ETJ7Z6XBU4
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe North America, Inc.94de9ce3-6ee9-4322-bda2-0b4391f09d872022-03-22WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da807eb3-34a3-61b9-e053-2995a90a0e212022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da80a5ea-f603-719e-e053-2995a90a97102022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da81b21a-090a-dabf-e053-2995a90aa05e2022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da821d05-b2f0-3582-e053-2a95a90afe592022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da717cf0-54af-c4e2-e053-2995a90ac97c2022-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
unii: ETJ7Z6XBU4
EAR RXACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUMMiami Beach Pediatrics paa8753f88-4b8a-472f-a4bd-f2e9cec836102021-12-29WarningsExact identifier
unii: ETJ7Z6XBU4
Lyme Disease Support 2ARGENTUM NITRICUM, ASTRAGALUS MENZIESII, CALCAREA SULPHURICA, CUPRUM ARSENICOSUM, DNA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI SULPHURICUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RNA, SILICEA.OHM PHARMA INC.13b4b78b-f9f7-4cf6-8f43-61679160086b2021-12-29WarningsExact identifier
unii: ETJ7Z6XBU4
Lyme Disease Support 1ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA.OHM PHARMA INC.035e75d6-aeef-4dfd-b076-9d3d8e4a50862021-12-29WarningsExact identifier
unii: ETJ7Z6XBU4
OHM Skin Healing CreamCALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.OHM PHARMA INC.c12e6706-37f0-4900-856c-fc7e7ac3b7242021-12-29WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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