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 | 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 |
|---|---|---|
| 16729-398-01 | 2023-02-01 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-398-15 | 2023-02-01 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-398-16 | 2023-02-01 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-398-17 | 2023-02-01 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-398-01 | 2023-01-30 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-398-15 | 2023-01-30 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-398-16 | 2023-01-30 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-398-17 | 2023-01-30 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16729-398-01 | isosorbide mononitrate | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 4 | |
| 16729-398-15 | isosorbide mononitrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 4 | |
| 16729-398-16 | isosorbide mononitrate | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 4 | |
| 16729-398-17 | 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 |
|---|---|---|---|---|---|---|
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Edenbridge Pharmaceuticals LLC. | 0e3c4461-2e04-481f-a9e5-29f21cc71ec5 | 2025-06-06 | Warnings, Adverse reactions | 317110 353538 LX1OH63030 |
| BioTox Dental Foci Repair | ARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEA | The Wellness Center For Research and Education | 767f8dd2-759f-4662-9b5c-b8832309363d | 2025-06-06 | Warnings | ETJ7Z6XBU4 |
| Silicea 6X | SILICEA 6X | True Botanica, LLC | 2cee8f0b-6d28-75e4-e063-6294a90a2e15 | 2025-06-05 | Warnings | ETJ7Z6XBU4 |
| VACC HC | ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, RNA, SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUM | Deseret Biologicals, Inc. | 5e37c522-a821-4673-9220-b59c73957445 | 2025-05-27 | Warnings | ETJ7Z6XBU4 |
| Sinus Tonic | ECHINACEA (ANGUSTIFOLIA), BAPTISIA TINCTORIA, THIAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, PYRIDOXINUM HYDROCHLORICUM, SPONGIA TOSTA, APIS MELLIFICA, ASCORBIC ACID, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LACHESIS MUTUS, MERCURIUS IODATUS RUBER, MERCURIUS SULPHURATUS RUBER, PULSATILLA (PRATENSIS), SILICEA, SINUSITISINUM, PANTOTHENIC ACID | BioActive Nutritional, Inc. | 63234fdc-7456-42c6-8996-fef372dd4a53 | 2025-05-20 | Warnings | ETJ7Z6XBU4 |
| Inflammation I | ECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEA | BioActive Nutritional, Inc. | ddfad5cd-c928-42c0-9562-9feebb73a2cb | 2025-05-19 | Warnings | ETJ7Z6XBU4 |
| Vermex | ARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUM | BioActive Nutritional, Inc. | 06b61e15-ab8b-4b7e-8378-48f87a963e44 | 2025-05-16 | Warnings | ETJ7Z6XBU4 |
| Lymph II | ECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANA | BioActive Nutritional, Inc. | 678874d0-7600-4d03-ad1e-e4dc67157597 | 2025-05-16 | Warnings | ETJ7Z6XBU4 |
| Vax Sode | THUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI(CLOSTRIDIUM TETANI), MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICA, SALMONELLA ENTERIDITIS | Nutritional Specialties, Inc. | 6f8cfcad-4d23-44d3-9369-22b575b1e7e6 | 2025-05-15 | Warnings | ETJ7Z6XBU4 |
| Apnetem | PHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME A | Nucleic Products, LLC | ec5bc7e7-4be6-45a6-8cd9-62fdfa7fb469 | 2025-05-14 | Warnings | ETJ7Z6XBU4 |
| DOCTRUST ONE S Tooth | SODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATE | DOCSMEDI Co., Ltd. | 3382776a-a10e-1823-e063-6394a90a6f91 | 2025-04-24 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM238 | SANTONINE, CINA, SILICEA, INDIGO, AMBROSIA, CUCCURBITA CIT, CUCCURBITA PEP | Bestmade Natural Products | 298fb9e2-3f98-01e6-e063-6294a90a7aaf | 2025-03-26 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM60 | CIMICIFUGAD6, DROSERAD6, FORMICA RUFAD6, FULIGOD6, INULA HELD6, KALI MURD6, LAPIS ALBUSD6, SILICEAD6 | Bestmade Natural Products | 29912fb7-8712-18d9-e063-6394a90a82f7 | 2025-03-25 | Warnings | ETJ7Z6XBU4 |
| Natural Eyes Stye Relief Fast Dissolving Tables | APIS MELLIFICA, CARBONEUM SULPHURATUM, PULSATILLA, SEPIA, SILICEA | TRP Company | 30a5435b-32b0-807d-e063-6294a90a84da | 2025-03-18 | 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 HISPANA, X-RAY, YTTERBIUM OXIDE | Deseret Biologicals, Inc. | 00a2c1c7-2c04-4c71-9276-24ba87288d61 | 2025-03-17 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM231 | ABROTANUM, ANTI IOD, ARSENIC IOD, BARYTA CARB, CALC PHOS, FERR MET, KALI IOD, SILICEA | Bestmade Natural Products | 2f81507c-b5b0-a976-e063-6394a90a869e | 2025-03-04 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM237 | BELLADONA, BARYTA CARB, HEPAR SULPH, KALI BICH, MERC IOD FLAV, MERC IOD RUB, SILICEA | Bestmade Natural Products | 2f82f2c4-a549-9e17-e063-6394a90aea81 | 2025-03-04 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM214 | CARBO VEG, FERRUM PHOS, SILICA, KALI CARB, CALC PHOS, NAT MUR | Bestmade Natural Products | 2f6e08d8-a6f9-c049-e063-6394a90a6df1 | 2025-03-03 | Warnings | ETJ7Z6XBU4 |
| YVTYVT MICRODERMABRASION FACIAL SCRUB | YVTYVT MICRODERMABRASION FACIAL SCRUB | Beijing JUNGE Technology Co., Ltd. | 2f30fc45-42e2-c766-e063-6394a90a8d68 | 2025-02-28 | Warnings | OP1R32D61U |
| Silicea | SILICON DIOXIDE | Washington Homeopathic Products | 2ee71a08-f69b-e2ef-e063-6394a90ab990 | 2025-02-24 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.