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 |
|---|---|---|---|---|---|---|
| ReHydration | ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM | Energetix Corporation | 37063a49-6b45-4167-875d-49c9dac3f79b | 2024-11-20 | 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. | 2be630bc-9fa6-42a6-b66d-99f91a58b1fa | 2024-11-15 | Warnings | ETJ7Z6XBU4 |
| Focus | ADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUM | Deseret Biologicals, Inc. | e014e6b6-a07a-4170-b9af-f477da71597d | 2024-11-13 | Warnings | ETJ7Z6XBU4 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Golden State Medical Supply, Inc. | 86be0e85-5337-bee4-e053-2a91aa0a8158 | 2024-11-11 | Warnings, Adverse reactions | 317110 311196 353538 LX1OH63030 |
| Chronagesic | ALPHA-LIPOICUM ACIDUM, APIOLUM, ARNICA MONTANA, CARTILAGO SUIS, CINNAMOMUM, DULCAMARA, FUNICULUS UMBILICALIS SUIS, NADIDUM, NATRUM OXALACETICUM, PANTOTHENIC ACID, PLACENTA TOTALIS SUIS, PIPER NIGRUM, RHUS TOX, SANGUINARIA CANADENSIS, SULPHUR, SILICEA, SYMPHYTUM OFFICINALE, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 1e340282-dbd9-44d7-9924-807f4099cf0c | 2024-11-08 | Warnings | ETJ7Z6XBU4 |
| Sinus Congestion Headache | ANTIMONIUM TARTARICUM, ASAFOETIDA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIA PILULIFERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IODIUM, KALI BICHROMICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MUCOSA NASALIS SUIS, PULSATILLA (PRATENSIS), PYROGENIUM, SILICEA, TEUCRIUM MARUM | Liddell Laboratories, Inc. | debc7747-8664-4598-a862-e295188c4fca | 2024-11-04 | Warnings | ETJ7Z6XBU4 |
| Vaccines | ARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENS | Liddell Laboratories, Inc. | 6e6e67d4-089e-4775-b4a4-5511953f6e3f | 2024-11-04 | Warnings | ETJ7Z6XBU4 |
| Vaccistat | BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUM | Energique, Inc. | 8c8d63b6-763a-44f8-87ef-e83a89ec3776 | 2024-10-31 | Warnings | ETJ7Z6XBU4 |
| Vaccistat | BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUM | Energique, Inc. | 5205cc3e-c9bc-48e9-9c9b-959a9be78b85 | 2024-10-31 | Warnings | ETJ7Z6XBU4 |
| Silicea | SILICEA | Energique, Inc. | 7ac17e38-d6e2-4cc9-8fcb-cbfa0d60223b | 2024-10-30 | Warnings | ETJ7Z6XBU4 |
| Scarstat | CALENDULA OFFICINALIS, GRAPHITES, HYPERICUM PERFORATUM, SILICEA, STAPHYSAGRIA, THIOSINAMINUM | Energique, Inc. | 1decc2eb-1261-46b8-908e-a152535b4a02 | 2024-10-30 | Warnings | ETJ7Z6XBU4 |
| SILICEA | SILICEA | Energique, Inc. | 395f400d-6a87-4da9-aa1f-edca9729f1ac | 2024-10-30 | Warnings | ETJ7Z6XBU4 |
| Scrophulous HP | BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, GNAPHALIUM POLYCEPHALUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEA | Energique, Inc. | e50eb26b-6843-4b8f-8ea5-3d5f57a3e7b4 | 2024-10-30 | Warnings | ETJ7Z6XBU4 |
| Chavita 1 | CARBO VEG, OOPHORINUM, SILICEA, OLIBANUM, ORCHITINUM, URTICA URENS | RUBIMED AG | 0ade088f-0ff2-4894-9aed-d0b0cfdde38d | 2024-10-29 | Warnings | ETJ7Z6XBU4 |
| Pulmopar | LOBELIA INFLATA, LUNG (SUIS), SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, BLATTA ORIENTALIS, BRYONIA (ALBA), PHOSPHORUS, SILICEA, SULPHUR | Energique, Inc. | 1cfb69c5-dc01-4acc-8053-5ca4e64165dc | 2024-10-29 | Warnings | ETJ7Z6XBU4 |
| Multi-Cell Salt | KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CALCAREA SULPHURICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SILICEA | Energique, Inc. | dad00225-b3ac-4e36-a856-19b0faf42c42 | 2024-10-29 | Warnings | ETJ7Z6XBU4 |
| Otoflam HP | BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA. | Energique, Inc. | 76c6b494-43d1-4508-bea4-4f9026b4a5fa | 2024-10-29 | Warnings | ETJ7Z6XBU4 |
| Silicea 30X | SILICON DIOXIDE | True Botanica, LLC | 1d99c26a-3f95-c138-e063-6294a90a9d62 | 2024-10-28 | 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. | ed3e0362-a4d3-46fa-a045-17bf659b777c | 2024-10-28 | Warnings | ETJ7Z6XBU4 |
| Hypothalmupar | ARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PHOSPHORUS, SILICEA | Energique, Inc. | 8b01e718-83b7-4f93-8fea-d0e37c756185 | 2024-10-28 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.