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 |
|---|---|---|---|---|---|---|
| SUPREN | ARSENIC TRIOXIDE, SULFURIC ACID, CHAMAELIRIUM LUTEUM ROOT, GOLDENSEAL, WOOD CREOSOTE, LEMNA MINOR, MAGNESIUM FLUORIDE, AND SILICON DIOXIDE | PEKANA Naturheilmittel GmbH | 3b34740c-b181-4f05-9858-15b7211a4c67 | 2022-12-22 | Warnings | ETJ7Z6XBU4 |
| KELAN | SILICON DIOXIDE, ARNICA MONTANA ROOT, GRAPHITE, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, MAGNESIUM FLUORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, AND RUTA GRAVEOLENS FLOWERING TOP | PEKANA Naturheilmittel GmbH | 55786d99-ee1f-490f-9023-3e6c39da86b0 | 2022-12-22 | Warnings | ETJ7Z6XBU4 |
| COLIC CP | AETHUSA CYNAPIUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SILICON DIOXIDE, SULFUR. | Natural Creations, Inc. | 7c2a2f6e-a332-4c68-a7a8-fdc390f1827e | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f0315c9e-8922-c0b5-e053-2a95a90ae54e | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f031e256-fca5-3939-e053-2995a90a4fe6 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| SILICEA | SILICON DIOXIDE | Hyland's Inc. | 86da31ff-b39a-4ac2-92e5-810f6d8888e6 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f0328097-e5d2-3532-e053-2a95a90a93f0 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f032e7bb-a6fd-2951-e053-2a95a90a8c3a | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Silicea | SILICON DIOXIDE | Hyland's Inc. | d3c426ab-1a61-3494-e053-2a95a90a9677 | 2022-12-14 | Warnings | ETJ7Z6XBU4 |
| Silicea | SILICEA | Hahnemann Laboratories, INC. | efcdc393-5dab-38d1-e053-2995a90acb2e | 2022-12-14 | ETJ7Z6XBU4 | |
| Defend Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | bb851be1-0528-4199-91e7-e09f994b2862 | 2022-12-12 | Warnings | ETJ7Z6XBU4 |
| Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic Combination | CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA | OHM PHARMA INC. | 044a7174-f7a3-490f-9cad-01f2665d7575 | 2022-12-02 | Warnings | ETJ7Z6XBU4 |
| 4 Kids Cold and Mucus Nighttime | EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR | Hyland's Inc. | 6f7b2585-2f0e-5938-e053-2a91aa0aa9d1 | 2022-11-21 | Warnings | ETJ7Z6XBU4 |
| 4 Kids Complete Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | ef39fe3d-a42d-4baa-9199-91f664feb432 | 2022-11-21 | Warnings | ETJ7Z6XBU4 |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | Aurobindo Pharma Limited | 55810c9d-1140-40b8-a297-210a84afc05a | 2022-11-11 | Warnings, Adverse reactions | 317110 311196 353538 LX1OH63030 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Actavis Pharma, Inc. | ae8f74f0-e600-4452-8557-958b603e2709 | 2022-10-01 | Warnings, Adverse reactions | LX1OH63030 |
| Hendel Periodontal and Tooth Pain Relief | SODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDE | MediNatura Inc | f34e9f77-69fd-4c7f-9eea-2d721a4d27fb | 2022-08-22 | Warnings | ETJ7Z6XBU4 |
| ALPHA SH | SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS | Schwabe Mexico, S.A. de C.V. | 3e2e5f52-db54-4635-83a8-a67a683c093c | 2022-03-22 | Warnings | ETJ7Z6XBU4 |
| ALPHA SH | SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS | Schwabe North America, Inc. | 94de9ce3-6ee9-4322-bda2-0b4391f09d87 | 2022-03-22 | Warnings | ETJ7Z6XBU4 |
| Ear Care | ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM | Newton Laboratories, Inc. | da807eb3-34a3-61b9-e053-2995a90a0e21 | 2022-03-18 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.