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 | Type |
|---|---|---|---|
| isosorbide mononitrate - Accord Healthcare Inc. | Intas Pharmaceuticals Limited | Accord Healthcare Inc. | Intas Pharmaceuticals Limited | 2023-02-01 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 16729-397-01 | 2023-02-01 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-397-15 | 2023-02-01 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-397-16 | 2023-02-01 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-397-17 | 2023-02-01 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-397-01 | 2023-01-30 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-397-15 | 2023-01-30 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-397-16 | 2023-01-30 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-397-17 | 2023-01-30 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16729-397-01 | isosorbide mononitrate | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 4 | |
| 16729-397-15 | isosorbide mononitrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 4 | |
| 16729-397-16 | isosorbide mononitrate | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 4 | |
| 16729-397-17 | isosorbide mononitrate | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | 4 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CellTropin | ARGININE, GINKGO BILOBA, HYPOPHYSIS SUIS, SILICEA, ASTRAGALUS EXCAPUS | Micro Balance Health Products LLC | 502d3ffa-bbf4-403a-9fad-b6b229f36a8c | 2023-02-14 | Warnings | ETJ7Z6XBU4 |
| f3a780ee-b09a-58a1-e053-2995a90a1fa2 | cd439861-2e23-4e0e-bcdc-48e2ebdc4943 | 2023-02-01 | Warnings, Adverse reactions | f3a780ee-b09a-58a1-e053-2995a90a1fa2 cd439861-2e23-4e0e-bcdc-48e2ebdc4943 | ||
| Silicea | SILICON DIOXIDE | Boiron | 86d2db09-9c46-37f7-e053-2a91aa0a326f | 2023-01-23 | ETJ7Z6XBU4 | |
| Silicea | SILICON DIOXIDE | Boiron | 86d3be33-b50e-e649-e053-2a91aa0acfc5 | 2023-01-23 | ETJ7Z6XBU4 | |
| Silicea | SILICON DIOXIDE | Boiron | 86d3be33-b4fb-e649-e053-2a91aa0acfc5 | 2023-01-23 | ETJ7Z6XBU4 | |
| Gyno Complex | VIBURNUM OPULUS, MAGNESIA PHOSPHORICA, FOLLICULINUM, PULSATILLA (PRATENSIS), BORAX, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALIS | Deseret Biologicals, Inc | dfaaa56a-4226-4f62-a219-d3f89fe7afe3 | 2023-01-12 | Warnings | ETJ7Z6XBU4 |
| Silicea | SILICON DIOXIDE | Boiron | 86d367e5-e846-54ba-e053-2991aa0a63d4 | 2023-01-12 | ETJ7Z6XBU4 | |
| Perfect Sleep | ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, UBIDECARENONUM, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, MELATONIN, PYRROLE, TRYPTOPHAN, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS | Deseret Biologicals, Inc. | f267fff4-f331-49b8-bd48-7d383da52246 | 2023-01-11 | Warnings | ETJ7Z6XBU4 |
| DALEKTRO N | SILVER NITRATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, COBALTOUS NITRATE HEXAHYDRATE, CUPRIC ACETATE, IRON, POTASSIUM CARBONATE, MAGNESIUM CHLORIDE, MANGANESE ACETATE TETRAHYDRATE, SELENIUM, SILICON DIOXIDE, AND ZINC PHOSPHIDE | PEKANA Natruheilmittel GmbH | 2b39ce30-54ff-4586-bda1-d9410140b26e | 2023-01-11 | Warnings | ETJ7Z6XBU4 |
| Rehydrate | AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN | ParaDocs All Natural, Inc. | 648fab10-c46b-420f-a42c-6642009d83fb | 2023-01-10 | Warnings | ETJ7Z6XBU4 |
| SUPREN | ARSENIC TRIOXIDE, SULFURIC ACID, CHAMAELIRIUM LUTEUM ROOT, GOLDENSEAL, WOOD CREOSOTE, LEMNA MINOR, MAGNESIUM FLUORIDE, AND SILICON DIOXIDE | PEKANA Naturheilmittel GmbH | 3b34740c-b181-4f05-9858-15b7211a4c67 | 2022-12-22 | Warnings | ETJ7Z6XBU4 |
| KELAN | SILICON DIOXIDE, ARNICA MONTANA ROOT, GRAPHITE, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, MAGNESIUM FLUORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, AND RUTA GRAVEOLENS FLOWERING TOP | PEKANA Naturheilmittel GmbH | 55786d99-ee1f-490f-9023-3e6c39da86b0 | 2022-12-22 | Warnings | ETJ7Z6XBU4 |
| COLIC CP | AETHUSA CYNAPIUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SILICON DIOXIDE, SULFUR. | Natural Creations, Inc. | 7c2a2f6e-a332-4c68-a7a8-fdc390f1827e | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f0315c9e-8922-c0b5-e053-2a95a90ae54e | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f031e256-fca5-3939-e053-2995a90a4fe6 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| SILICEA | SILICON DIOXIDE | Hyland's Inc. | 86da31ff-b39a-4ac2-92e5-810f6d8888e6 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f0328097-e5d2-3532-e053-2a95a90a93f0 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f032e7bb-a6fd-2951-e053-2a95a90a8c3a | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Cataracc | ARSENICUM ALB., BRYONIA, CALC. FLUOR., CALENDULA, CAUSTICUM, CONIUM, EUPHRASIA, HYDROFLUORICUM AC., IODIUM, LEDUM, NAPHTHALINUM, NAT. MUR., NUX VOM., PHOS., PULSATILLA, SEPIA, SILICEA, TELLURIUM, THIOSINAMINUM, ZINC. MET. | Newton Laboratories, Inc. | eff981fd-5436-7c34-e053-2a95a90a3e8e | 2022-12-16 | Warnings | ETJ7Z6XBU4 |
| Silicea | SILICON DIOXIDE | Hyland's Inc. | d3c426ab-1a61-3494-e053-2a95a90a9677 | 2022-12-14 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.