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 |
|---|---|---|---|---|---|---|
| SILICEA 6X | SILICEA | SEVENE USA | ff0e0009-8bbe-e0eb-e053-6294a90afa82 | 2025-02-11 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM127 | CALC CARB, LYCOPODIUM, SENEGA, SILICEA, STICTA PULM, YERBA SANTA | Bestmade Natural Products | 2dcc5468-9b11-b6d5-e063-6294a90a4139 | 2025-02-10 | Warnings | ETJ7Z6XBU4 |
| 12 CELL SALTS COMPLEX | CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA | SEVENE USA | ff0f69cd-97a2-7183-e053-6394a90ad039 | 2025-02-10 | Warnings | ETJ7Z6XBU4 |
| SILICEA 200ck | SILICEA | SEVENE USA | cf89bb22-9e2f-9143-e053-2995a90aff19 | 2025-02-10 | Warnings | ETJ7Z6XBU4 |
| Teeth-Gums | CHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIA | Newton Laboratories, Inc. | 9d27b1e4-a966-5495-e053-2a95a90a965b | 2025-02-10 | Warnings | ETJ7Z6XBU4 |
| Teeth-Gums | CHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIA | Newton Laboratories, Inc. | 9d363a40-a17b-2b6f-e053-2a95a90a3384 | 2025-02-10 | Warnings | ETJ7Z6XBU4 |
| Dust-Mold-Dander | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE. | Newton Laboratories, Inc. | 99fdc906-3a55-e4c4-e053-2a95a90a76ba | 2025-02-10 | Warnings | ETJ7Z6XBU4 |
| Leg Cramps-Swelling | ECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPS | Newton Laboratories, Inc. | 9c315126-e61e-f649-e053-2a95a90a7f08 | 2025-02-07 | Warnings | ETJ7Z6XBU4 |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | Coupler LLC | 2d99893a-296a-134c-e063-6294a90ace3b | 2025-02-07 | Warnings, Adverse reactions | 317110 LX1OH63030 |
| Dust-Mold-Dander | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE. | Newton Laboratories, Inc. | 9bb84bae-9019-ed76-e053-2a95a90a5c3e | 2025-02-06 | Warnings | ETJ7Z6XBU4 |
| Dust-Mold-Dander | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE. | Newton Laboratories, Inc. | 9ba993f4-97af-4119-e053-2995a90a126d | 2025-02-06 | Warnings | ETJ7Z6XBU4 |
| Ear Wax Build-Up | ELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATA | Newton Laboratories, Inc. | 9302b838-6003-ba6a-e053-2995a90aedd3 | 2025-02-06 | Warnings | ETJ7Z6XBU4 |
| PRID | ICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFUR | Hyland's Inc. | d22eca2f-d7e6-3412-e053-2995a90a6384 | 2025-02-05 | Warnings | ETJ7Z6XBU4 |
| Jacksons Cell Salts 12 IN 1 | CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA | Zettl Health Inc. | 25ba49d0-0369-3666-e063-6294a90a71c4 | 2025-02-04 | ETJ7Z6XBU4 | |
| Jacksons Cell Salts SILICA 6X 12 | SILICEA | Zettl Health Inc. | 2d5d1bf7-3754-1f60-e063-6294a90aee06 | 2025-02-04 | ETJ7Z6XBU4 | |
| Constipation | ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUM | Newton Laboratories, Inc. | 9d63b107-cd47-d9a5-e053-2a95a90a4493 | 2025-01-28 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM55 | DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUM | Bestmade Natural Products | 2c751942-5b36-8558-e063-6294a90af87a | 2025-01-24 | Warnings | ETJ7Z6XBU4 |
| Constipation | ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUM | Newton Laboratories, Inc. | 9d626292-7abb-1afb-e053-2995a90a2818 | 2025-01-24 | Warnings | ETJ7Z6XBU4 |
| DOCTRUST K Tooth | SILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATE | DOCSMEDI Co., Ltd. | a02f8865-e7be-4ef4-b09c-dad846639764 | 2025-01-22 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products Bio4 | CALC FLUOR, KALI MUR, NAT MUR, SILICEA | Bestmade Natural Products | ea224687-106e-3821-e053-2995a90aa69c | 2025-01-22 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.