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 |
|---|---|---|---|---|---|---|
| Cough plus Bronchial | ANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENS | Liddell Laboratories, Inc. | 801eba42-4217-46e9-8f3e-745da01a27b0 | 2024-07-01 | Warnings | ETJ7Z6XBU4 |
| Argentum Quartz 6X | ARGENTUM QUARTZ 6X | True Botanica, LLC | 1acadf89-d222-9e16-e063-6294a90a80bc | 2024-06-26 | Warnings | ETJ7Z6XBU4 |
| Cold Sore Rescue | BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA | Peaceful Mountain, Inc. | a7fe6ec7-a758-43cf-b46f-c327e0632fb8 | 2024-06-13 | Warnings | ETJ7Z6XBU4 |
| SILICEA | SILICEA | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | 1a361030-a925-0998-e063-6394a90a915d | 2024-06-06 | Warnings | ETJ7Z6XBU4 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | NuCare Pharmaceuticals,Inc. | 65935a15-a023-1941-e053-2991aa0a5eb4 | 2024-06-06 | Warnings, Adverse reactions | 317110 LX1OH63030 |
| Multiple Miasm | ACONITUM NAPELLUS, ALOE, ARSENICUM ALBUM, AURUM METALLICUM, BRYONIA (ALBA), CACTUS GRANDIFLORUS, CALCAREA SULPHURICA, CINCHONA OFFICINALIS, HURA BRASILIENSIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, PHOSPHORUS, SARCOLACTICUM ACIDUM, SILICEA, STRAMONIUM, SULPHUR, TARENTULA HISPANA, TEUCRIUM MARUM, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 92c97bf6-8dd9-43a9-b686-75420b029197 | 2024-05-21 | Warnings | ETJ7Z6XBU4 |
| Osteopar | EQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OLEUM MORRHUAE, SILICEA, HEKLA LAVA | Energique, Inc. | 6c346a26-26a2-4be0-b8a3-bbb5709bcf3d | 2024-05-21 | Warnings | ETJ7Z6XBU4 |
| Colopar | COLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALIS | Energique, Inc. | c47d7203-abcd-4ae5-bf9b-5df07e07d3c1 | 2024-05-20 | Warnings | ETJ7Z6XBU4 |
| Aging Eye Formula | CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUM | Nutritional Specialties, Inc. | 4510fe59-cc28-4585-925f-42508a60abd0 | 2024-05-13 | Warnings | ETJ7Z6XBU4 |
| EMF Protect and Balance | ALFALFA, FUCUS VESICULOSUS, KALI PHOSPHORICUM, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, FERRUM METALLICUM, CADMIUM SULPHURATUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, YTTERBIUM OXIDE, TARENTULA CUBENSIS, X-RAY, CUPRUM METALLICUM, SILICEA | Deseret Biologicals, Inc. | df7e925e-00d1-4b0c-8a78-ad38148bc360 | 2024-05-09 | Warnings | ETJ7Z6XBU4 |
| Multiple Miasm | ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, SULPHUR, ALOE, CARCINOSIN, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 0cf54ec3-d731-4f27-89fd-4571d991a615 | 2024-05-09 | Warnings | ETJ7Z6XBU4 |
| Osteopar | EQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OSSA SEPIA, SILICEA, HEKLA LAVA | Energique, Inc. | daf83dbf-bbf4-49e2-ade1-1d86f3e52675 | 2024-05-09 | Warnings | ETJ7Z6XBU4 |
| Occuloplex I | EUPHRASIA OFFICINALIS, GINKGO BILOBA, TARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, GLUTATHIONE, UBIDECARENONUM, ZINCUM GLUCONICUM, CITRUS BIOFLAVONOIDS, EYE (SUIS), AMMONIUM MURIATICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, CYANOCOBALAMIN, GERMANIUM SESQUIOXIDE, MAGNESIA CARBONICA, SELENIUM DIOXIDE, SILICEA, BETA CAROTENE | BioActive Nutritional, Inc. | c2c9b577-4f75-4ddc-815f-46c3bb9b46d2 | 2024-05-08 | Warnings | ETJ7Z6XBU4 |
| Lymphoplus | TRIFOLIUM PRATENSE, LYMPH NODE (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), LYCOPODIUM CLAVATUM, MYRRHA, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA | Deseret Biologicals, Inc. | 92f6fc6b-58c0-4137-88b3-bee2118aeb29 | 2024-05-08 | Warnings | ETJ7Z6XBU4 |
| B HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEA | Energique, Inc. | a1b42f4b-4029-4008-b950-a7725f34b43d | 2024-05-08 | Warnings | ETJ7Z6XBU4 |
| B HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SILICEA | Energique, Inc. | 04dfad30-9496-43c6-8ce8-ab04fdb9ce3b | 2024-05-06 | Warnings | ETJ7Z6XBU4 |
| AI Miasm | ASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, SCROPHULARIA NODOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUM | Energique, Inc. | df829e4a-c982-4d02-b318-38b1fbc5072d | 2024-05-02 | Warnings | ETJ7Z6XBU4 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Aphena Pharma Solutions - Tennessee, LLC | 17525ff2-9ec0-15a1-e063-6394a90ab762 | 2024-04-30 | Warnings, Adverse reactions | 317110 LX1OH63030 |
| VACC HC | HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUM | Deseret Biologicals, Inc. | a98082ba-21ec-4cf8-b81c-bcb41eb9fd12 | 2024-04-23 | Warnings | ETJ7Z6XBU4 |
| Ligapar | LAPPA MAJOR, LIGAMENT (HUMAN), CARTILAGO SUIS, ARNICA MONTANA, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CAUSTICUM, RHODODENDRON CHRYSANTHUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA, ZINCUM METALLICUM | Energique, Inc. | 17f6b1f5-8e49-49df-bad4-9c19fa677e69 | 2024-04-22 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.