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 |
|---|---|---|---|---|---|---|
| FATIGUE NOSODE EB | ASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARANEA DIADEMA, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA, SEPIA, EPSTEIN-BARR VIRUS NOSODE | Energique, Inc. | 36d963cc-fd47-40ee-aa73-c2e7fcedf192 | 2024-10-24 | Warnings | ETJ7Z6XBU4 |
| Complexion HP | CARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUM | Energique, Inc. | ad12d51e-04cb-4833-b802-0038796966ff | 2024-10-24 | Warnings | ETJ7Z6XBU4 |
| Granite 30X | GRANITE 30X | True Botanica, LLC | 21b2bae6-8176-ccbf-e063-6394a90a97b5 | 2024-10-07 | Warnings | ETJ7Z6XBU4 |
| EMF Protect and Balance | ALFALFA, CADMIUM SULPHURATUM, CALCAREA CARBONICA, CUPRUM METALLICUM, FERRUM METALLICUM, FUCUS VESICULOSUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, SILICEA, SYMPHYTUM OFFICINALE, TARENTULA CUBENSIS, X-RAY, YTTERBIUM OXIDE | Deseret Biologicals, Inc. | 9ea8dfe3-7d95-4b86-8e1f-dc9e414e854a | 2024-10-04 | Warnings | ETJ7Z6XBU4 |
| Hydration Complex | BOLDO, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, HYPERICUM PERFORATUM, GINKGO BILOBA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, GERMANIUM SESQUIOXIDE, SILICEA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA | Deseret Biologicals, Inc. | 891265ff-2651-4d84-a77b-331e3eb7e3ec | 2024-10-04 | Warnings | ETJ7Z6XBU4 |
| Bone Support HP | CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPATORIUM PERFOLIATUM, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA, STRONTIUM CARBONICUM, SYMPHYTUM OFFICINALE | Energique, Inc. | da6937b9-da23-4e78-96af-2ca40f973a02 | 2024-09-30 | Warnings | ETJ7Z6XBU4 |
| Lymphapar | ECHINACEA (ANGUSTIFOLIA), LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM , KALI MURIATICUM, LACHESIS MUTUS, SILICEA | Energique, Inc. | c746c111-7ebc-46c1-b11b-04271887df9c | 2024-09-23 | Warnings | ETJ7Z6XBU4 |
| HP Axis | ARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONE | Deseret Biologicals, Inc. | 402f5b05-c71e-4dba-bc2b-049aee42952a | 2024-09-23 | Warnings | ETJ7Z6XBU4 |
| Chronagesic | ARNICA MONTANA, CINNAMOMUM, DULCAMARA, FUNICULUS UMBILICALIS SUIS, NADIDUM, NATRUM OXALACETICUM, PANTOTHENIC ACID, PLACENTA TOTALIS SUIS, SANGUINARIA CANADENSIS, SULPHUR, PIPER NIGRUM, ALPHA-LIPOICUM ACIDUM, CARTILAGO SUIS, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALE, THUJA OCCIDENTALIS, APIOLUM | Deseret Biologicals, Inc. | 66e351ed-d359-4367-a950-fc57b37489ab | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| VACC HC | ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LAC FELINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, RNA, SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUM. | Deseret Biologicals, Inc. | a7536e3d-2cdb-49d7-9161-92ef64433883 | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| Focus | GINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, IODIUM, PHOSPHORUS, SARCOLACTICUM ACID, SACCHARUM OFFICINALE, ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, SILICEA, ADRENALINUM, AMBRA GRISEA, CARBONEUM SULPHURATUM, TARENTULA HISPANA, AETHUSA CYNAPIUM, BARYTA CARBONICA, HELLEBORUS NIGER, VERATRUM ALBUM, CANDIDA ALBICANS, HYOSCYAMUS NIGER | Deseret Biologicals, Inc. | e77857b8-be67-4041-8c8d-9772f17c6d06 | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| Mammaryplex | ECHINACEA (ANGUSTIFOLIA), MYRRHA, TRIGONELLA FOENUM-GRAECUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, LYMPH (SUIS), SPLEEN (SUIS), BRYONIA (ALBA), CONIUM MACULATUM, LAC CANINUM, LACHESIS MUTUS, SILICEA, BUFO RANA, MAMMARY GLAND (BOVINE) | BioActive Nutritional, Inc. | 9c9ed6f6-8690-4fbd-8691-26dd577014a8 | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| Lymph Liquescence | ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, ARSENICUM IODATUM, CURCUMA LONGA, SPLEEN (BOVINE), THYMUS (OVINE), CONIUM MACULATUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, SILICEA, ASTERIAS RUBENS, HYDRASTIS CANADENSIS, BUFO RANA | Nutritional Specialties, Inc. | 866ac8e1-431c-4c8b-b052-f6c4cff3769b | 2024-09-05 | Warnings | ETJ7Z6XBU4 |
| Geopathic Stress | ALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, SYMPHYTUM OFFICINALE, AGATE, CALCAREA CARBONICA, FERRUM METALLICUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, X-RAY, CUPRUM METALLICUM, TARENTULA HISPANA | BioActive Nutritional, Inc. | 7f4a18fc-1188-4201-85d5-f2d4d9d3fb7b | 2024-08-29 | Warnings | ETJ7Z6XBU4 |
| ASP | ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BRYONIA (ALBA), COCCULUS INDICUS, COLCHICUM AUTUMNALE, LEDUM PALUSTRE, MERCURIUS CYANATUS, NATRUM SULPHURICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, AFLATOXIN (B1) | BioActive Nutritional, Inc. | 66fe5457-fe15-4e33-b47e-2c0dc9b171f6 | 2024-08-28 | Warnings | ETJ7Z6XBU4 |
| Vermiclear | GRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUM | Energique, Inc. | f9df74a8-f225-44ca-91ba-dca4f3f35da0 | 2024-08-13 | Warnings | ETJ7Z6XBU4 |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | NCS HealthCare of KY, LLC dba Vangard Labs | ba6120c8-c885-4cfa-b68e-9eee7a3bad6d | 2024-08-13 | Warnings, Adverse reactions | 353538 LX1OH63030 |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | NCS HealthCare of KY, LLC dba Vangard Labs | 63dc518f-4f86-4820-98c2-5de8aed09a4b | 2024-08-13 | Warnings, Adverse reactions | 317110 LX1OH63030 |
| Mind Detox and Drainage | ALUMINA, BARYTA CARBONICA, CARBONEUM SULPHURATUM, CEREBRUM SUIS, CONIUM MACULATUM, HELLEBORUS NIGER, LECITHIN, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PICRICUM ACIDUM, PLATINUM METALLICUM, SILICEA, STRAMONIUM, SULPHURICUM ACIDUM, ZINCUM PHOSPHORATUM | Deseret Biologicals, Inc. | 1ac1e955-a374-4cac-b997-51c6aef8d35d | 2024-08-01 | Warnings | ETJ7Z6XBU4 |
| Terrestristat | ALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAY | Energique, Inc. | c3d2fd24-6b41-4c85-bd5f-c3306e97080e | 2024-07-03 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.