NDC 16729-396 - 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
- 16729-396
- Package NDCs from labels
- 16729-396-15, 16729-396-01, 16729-396-16, 16729-396-17
- 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 |
|---|---|---|
| 16729-396-01 | 2023-02-01 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-396-15 | 2023-02-01 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-396-16 | 2023-02-01 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-396-17 | 2023-02-01 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-396-01 | 2023-01-30 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-396-15 | 2023-01-30 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-396-16 | 2023-01-30 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 16729-396-17 | 2023-01-30 | Isosorbide Mononitrate Extended-Release Tablets Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16729-396-01 | isosorbide mononitrate | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 4 | |
| 16729-396-15 | isosorbide mononitrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 4 | |
| 16729-396-16 | isosorbide mononitrate | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 4 | |
| 16729-396-17 | 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 |
|---|---|---|---|---|---|---|
| Visiopar | EUPHRASIA OFFICINALIS, EYE (SUIS), AURUM METALLICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, MAGNESIA CARBONICA, PHOSPHORUS, SILICEA, PHYSOSTIGMA VENENOSUM, OSMIUM METALLICUM, THUJA OCCIDENTALIS | Energique, Inc. | 811f7626-0d21-49bd-8c31-9a5abec45c13 | 2024-04-19 | Warnings | ETJ7Z6XBU4 |
| EVTOX | COCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE | BioActive Nutritional, Inc. | 4b518e10-9ce0-492b-92be-6025d8d7c3c6 | 2024-04-19 | Warnings | ETJ7Z6XBU4 |
| VAXR HC | THUJA OCCIDENTALIS, MEZEREUM, SILICEA, CALCAREA CARBONICA, MORBILLINUM, PAROTIDINUM, PERTUSSINUM, RUBELLA NOSODE, TETANUS TOXIN, CARCINOSIN, ANTIMONIUM CRUDUM, LEDUM PALUSTRE, THIMEROSAL, POLIOMYELITIS NOSODE | Deseret Biologicals, Inc. | fdf8d21a-2ae1-4842-abf3-737841995939 | 2024-04-03 | Warnings | ETJ7Z6XBU4 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Bryant Ranch Prepack | 441ddd35-6cb8-44d0-8009-1635390ede83 | 2024-04-03 | Warnings, Adverse reactions | 317110 LX1OH63030 |
| Headache HP | BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM | Energique, Inc. | 5dca8670-c931-47e3-af89-b5f09f5f4e02 | 2024-03-26 | Warnings | ETJ7Z6XBU4 |
| PNEUMOPLEX | PLANTAGO MAJOR, ARSENICUM ALBUM, LUNG (BOVINE), SYMPHYTUM OFFICINALE, SILICEA, PHELLANDRIUM AQUATICUM, PHOSPHORUS, SULPHUR | BioActive Nutritional, Inc. | d839aea1-7725-40c1-b000-228843f75b93 | 2024-03-26 | Warnings | ETJ7Z6XBU4 |
| Lymphastat | BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUM | Energique, Inc. | 95406534-526e-4bca-b73d-1030623549a3 | 2024-03-26 | Warnings | ETJ7Z6XBU4 |
| Snore-Soothe | ECHINACEA, BRYONIA, CAMPHORA, CISTUS CANADENSIS, DROSERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IGNATIA AMARA, IODIUM, KALI BICHROMICUM, KALI IODATUM, PHOSPHORUS, PULSATILLA, SABADILLA, SILICEA, STICTA PULMONARIA, SULPHUR, TEUCRIUM MARUM, VERBASCUM THAPSUS, ARSENICUM ALBUM, BELLADONNA, HISTAMINUM HYDROCHLORICUM, LAC CANINUM, NUX VOMICA | Newton Laboratories, Inc. | 140a0bcf-82b3-c430-e063-6294a90ad38f | 2024-03-19 | Warnings | ETJ7Z6XBU4 |
| Dizzy | CEREBELLUM (SUIS), BRYONIA (ALBA), PETROLEUM, TABACUM, AMBRA GRISEA, CYCLAMEN EUROPAEUM, NATRUM SALICYLICUM, ARGENTUM NITRICUM, ASARUM CANADENSE, CALCAREA SULPHURICA, CARBONEUM SULPHURATUM, CHININUM SULPHURICUM, COCCULUS INDICUS, CONIUM MACULATUM, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, PHOSPHORUS, PIPER METHYSTICUM, SILICEA, THERIDION | Deseret Biologicals, Inc. | fdf934f8-7b12-4076-b8fb-00c095940697 | 2024-03-15 | Warnings | ETJ7Z6XBU4 |
| Ver | ARTEMISIA VULGARIS, ASCARIS LUMBRICOIDES, BRUGIA MALAYI, CALCAREA CARBONICA, CINA, CRYPTOSPORIDIUM PARVUM, ENTEROBIUS VERMICULARIS, FILIX MAS, GIARDIA LAMBLIA, GRAPHITES, IODIUM, MERCURIUS CORROSIVUS, QUASSIA (AMARA), SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TAENIA SAGINATA, TAENIA SOLIUM, TEUCRIUM MARUM, THYMUS SERPYLLUM, TRICHINELLA SPIRALIS, TRICHOMONAS VAGINALIS | Deseret Biologicals, Inc. | b47bdd57-14cd-46e9-a34e-0d8a7c21bda2 | 2024-03-12 | Warnings | ETJ7Z6XBU4 |
| Elevate | LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS) | Deseret Biologicals, Inc. | 5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b | 2024-03-11 | Warnings | ETJ7Z6XBU4 |
| Spinalmax | BERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS (SUIS), PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM | Deseret Biologicals, Inc. | 6c569331-2167-44bb-ace6-13340e7d8d6a | 2024-03-11 | Warnings | ETJ7Z6XBU4 |
| Perfect Sleep | ADENOSINUM TRIPHOSPHORICUM DINATRUM, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH), L-TRYPTOPHAN, MELATONIN, MERCURIUS CORROSIVUS, PANTOTHENIC ACID, PASSIFLORA INCARNATA, PINEAL GLAND (SUIS), PYRROLE, SARCOLACTICUM ACIDUM, SILICEA, UBIDECARENONUM, ZINCUM VALERIANICUM | Deseret Biologicals, Inc. | 81f29472-a2e6-486d-aefd-17135ad410ef | 2024-03-08 | Warnings | ETJ7Z6XBU4 |
| Kidney Drainage | SOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUM | Deseret Biologicals, Inc. | a030afc6-9248-4e6a-a814-bd700c053e5c | 2024-02-20 | Warnings | ETJ7Z6XBU4 |
| Cough | IPECACUANHA, STICTA PULMONARIA, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, SILICEA, TABACUM, PERTUSSINUM, TETANUS TOXIN | Deseret Biologicals, Inc. | 4a8deb4a-9f26-46a9-8d99-99df36407f22 | 2024-02-19 | Warnings | ETJ7Z6XBU4 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Aphena Pharma Solutions - Tennessee, LLC | 0af6c67f-919d-4515-8074-f6c3aaa835b5 | 2024-02-06 | Warnings, Adverse reactions | 353538 LX1OH63030 |
| Perfect Sleep | ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH) | Deseret Biologicals, Inc. | 6d934960-63c6-4536-bde3-38c26f8083dc | 2024-02-06 | Warnings | ETJ7Z6XBU4 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Aphena Pharma Solutions - Tennessee, LLC | 18cf36bc-e73f-4274-b381-c2f2aa02f57d | 2024-02-06 | Warnings, Adverse reactions | 317110 LX1OH63030 |
| Silicea | SILICON DIOXIDE | SEVENE USA | 0805d866-ce1a-4f54-8a44-83d4902e8c0d | 2024-01-30 | Warnings | ETJ7Z6XBU4 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | A-S Medication Solutions | adcca9b8-0505-4bbc-81ab-05efc7407b6b | 2024-01-23 | Warnings, Adverse reactions | 317110 LX1OH63030 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.