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 |
|---|---|---|---|---|---|---|
| Oral Care-Gingivitis | ACONITUM NAP., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CALENDULA, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM, HEPAR SULPH. CALC., KREOSOTUM, MERC. VIV., MYRRHA, NUX VOM., PHOSPHORUS, PHYTOLACCA, PLANTAGO, RHUS TOXICODENDRON, SILICEA, STAPHYSAG., ECHINACEA | Newton Laboratories, Inc. | 9971a7f4-c02c-02ba-e053-2a95a90a2b73 | 2020-12-04 | Warnings | ETJ7Z6XBU4 |
| Female Femroids | HYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, ARSENICUM ALBUM, CALCAREA IODATA, CARBO ANIMALIS, CONIUM MACULATUM, GRAPHITES, HYDRASTIS CANADENSIS, IODIUM, KREOSOTUM, LACHESIS MUTUS, PHOSPHORUS, SABINA, SECALE CORNUTUM, SEPIA, SILICEA, THLASPI BURSA-PASTORIS, THUJA OCCIDENTALIS, THYROIDINUM, TRILLIUM PENDULUM, USTILAGO MAIDIS. | Newton Laboratories, Inc. | 9a01acb9-1b2b-3a33-e053-2995a90adc92 | 2020-12-03 | Warnings | ETJ7Z6XBU4 |
| Fungal | CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC. | Newton Laboratories, Inc. | 99487f4a-76f6-407b-e053-2a95a90acfd4 | 2020-12-03 | Warnings | ETJ7Z6XBU4 |
| Thyroid-Adrenal | ADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEA | Newton Laboratories, Inc. | b59731a2-c775-7e8a-e053-2a95a90a9062 | 2020-12-03 | Warnings | ETJ7Z6XBU4 |
| Acne - Cystic Acne | ECHINACEA, JUGLANS REGIA, LAPPA MAJOR, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, AURUM METALLICUM, BERBERIS AQUIFOLIUM, BOVISTA, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, LEDUM PALUSTRE, LYCOPDIUM CLAVATUM, NUX VOMICA, SULPHUR IODATUM, ZINCUM METALLICUM, SILICEA | Newton Laboratories, Inc | 92afe017-74c7-16c6-e053-2995a90a5c7d | 2020-12-02 | Warnings | ETJ7Z6XBU4 |
| Breast Care - Fibrocystic | BUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUM | Newton Laboratories, Inc. | 98d01128-9887-12ce-e053-2a95a90a7329 | 2020-12-02 | Warnings | ETJ7Z6XBU4 |
| Thyroid-Adrenal | ADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEA | Newton Laboratories, Inc. | b56f2ffc-4637-1f23-e053-2a95a90aa3af | 2020-12-01 | Warnings | ETJ7Z6XBU4 |
| Hair-Scalp | APIS MEL., ARSENICUM ALB., CALC. CARB., DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, HYDROFLUORICUM ACIDUM, KALI CARB., LYCOPODIUM, MEZEREUM, OLEANDER, PETROLEUM, PHOSPHORICUM AC., PHOSPHORUS, RHUS TOXICODENDRON, SELENIUM, SEPIA, SILICEA, SULPHUR, THUJA OCC. | Newton Laboratories, Inc. | 9ab3b944-443c-74a1-e053-2a95a90aa0e5 | 2020-11-30 | Warnings | ETJ7Z6XBU4 |
| Acne | ANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUM | Newton Laboratories, Inc. | 798c853c-16ab-8502-e053-2a91aa0a6532 | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Acne | ANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUM | Newton Laboratories, Inc. | 798d5f34-819a-9895-e053-2991aa0a1d62 | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Breast Care | BUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUM | Newton Laboratories, Inc. | 79edde91-f909-f7b3-e053-2991aa0a9d1c | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Constipation | ABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUM | Newton Laboratories, Inc. | 90807700-3099-850c-e053-2995a90ada55 | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Constipation | ABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUM | Newton Laboratories, Inc. | 90804a94-1e67-3ab3-e053-2a95a90aafbe | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Post - Vaccination | INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM | Newton Laboratories, Inc. | 9042b7ad-15ed-0e81-e053-2a95a90afe28 | 2020-11-23 | Warnings | ETJ7Z6XBU4 |
| Post-Vaccination | INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM | Newton Laboratories, Inc. | 90bb15e5-3d9d-e2e2-e053-2995a90a85ac | 2020-11-23 | Warnings | ETJ7Z6XBU4 |
| GUNA MATRIX DETOX | SODIUM SULFATE - PODOPHYLLUM PELTATUM ROOT - SOLIDAGO VIRGAUREA FLOWERING TOP - APIS MELLIFERA - EQUISETUM HYEMALE - STRYCHNOS NUX VOMICA SEED - HAMAMELIS VIRGINIANA ROOT BARK STEM BARK - LYCOPODIUM CLAVATUM SPORE - GALIUM APARINE WHOLE - THUJA OCCIDENTALIS LEAFY TWIG - BERBERIS VULGARIS ROOT BARK - MYOSOTIS ARVENSIS - CHELIDONIUM MAJUS WHOLE - FUCUS VESICULOSUS - | Guna spa | a369b95b-4d57-f149-e053-2995a90a87e3 | 2020-10-23 | Warnings, Adverse reactions | ETJ7Z6XBU4 |
| Supreme | ABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEA | BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE | 72c4679b-aa97-4888-9178-581d0f99c0b6 | 2020-09-11 | Warnings | ETJ7Z6XBU4 |
| isosorbide mononitrate | ISOSORBIDE MONONITRATE | Lannett Company, Inc. | bf9e7e35-7707-42a0-88d6-6292fa52bbfa | 2020-06-05 | Warnings, Adverse reactions | LX1OH63030 |
| isosorbide mononitrate | ISOSORBIDE MONONITRATE | Proficient Rx LP | f871dfa7-219f-4704-8e4d-215caeb7408d | 2019-11-01 | Warnings, Adverse reactions | LX1OH63030 |
| Skin Klear Acne Relief | TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR | Homeocare Laboratories | 65afbc20-611b-4bc4-a151-c633bec66a82 | 2018-12-31 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.