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 |
|---|---|---|---|---|---|---|
| Bestmade Natural Products BM5 | APIS MELD3, BAPTISIAD4, CONIUM MACD8, ECHINACEAD2, EUPATORIUMD4, SILICEAD6, THUJA OCCD8 | Bestmade Natural Products | ebdcb53e-1767-cd08-e053-2995a90aedeb | 2025-01-22 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products Bio18 | CALC FLUOR, SILICEA, CALC SULPH | Bestmade Natural Products | eac337aa-11a1-5b17-e053-2a95a90ad19d | 2025-01-22 | Warnings | ETJ7Z6XBU4 |
| Lemon Quince | LEMON QUINCE | Uriel Pharmacy Inc | 332e4a40-e0f3-11de-8a39-0800200c9a66 | 2025-01-22 | Warnings | ETJ7Z6XBU4 |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | A-S Medication Solutions | 5fd86c08-18de-43a2-9962-ab6cbf57d6c0 | 2025-01-17 | Warnings, Adverse reactions | 317110 LX1OH63030 |
| Hydration Complex | BETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALE | Deseret Biologicals, Inc. | f60a2ab8-4146-4995-9bc6-be2660b17540 | 2025-01-16 | Warnings | ETJ7Z6XBU4 |
| D-34 | OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, CALCIUM HYPOPHOSPHITE, TRIBASIC CALCIUM PHOSPHATE, HEKLA LAVA, DAPHNE MEZEREUM BARK, MERCURIC OXIDE, SILICON DIOXIDE, AND MATRICARIA CHAMOMILLA | DNA Labs, Inc. | 607e21a3-2229-48fa-b12c-ebd3130b9996 | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-33 | ATROPA BELLADONNA, BUFO BUFO CUTANEOUS GLAND, COPPER, ANEMONE PRATENSIS, SILICON DIOXIDE, AND ZINC | DNA Labs, Inc. | 26f9bf6d-6038-42e8-b8c1-6c94ac4929af | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-86 | ARNICA MONTANA, SILICON DIOXIDE, SODIUM CHLORIDE, LEAD ACETATE ANHYDROUS, SELENICEREUS GRANDIFLORUS STEM, TRIBASIC CALCIUM PHOSPHATE, AND POTASSIUM IODIDE | DNA Labs, Inc. | 54fa62d3-c129-4826-a794-f3dcc6b855bf | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-57 | ARSENIC TRIIODIDE, PHOSPHORUS, TEUCRIUM SCORODONIA FLOWERING TOP, SILICON DIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND LYCOPODIUM CLAVATUM SPORE | DNA Labs, Inc. | 81cc16e7-921b-4b57-abeb-c44b9d72e4f3 | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-48 | PICRIC ACID, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, SOLANUM DULCAMARA WHOLE, POTASSIUM CARBONATE, PHOSPHORUS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, LYCOPODIUM CLAVATUM SPORE, AND FERROSOFERRIC PHOSPHATE | DNA Labs, Inc. | 1d55827f-0ea2-4eda-ae43-7c0723e5708e | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-132 | SILICON DIOXIDE | DNA Labs, Inc. | 3d8e499d-ebe2-45b9-b078-256268c42d4b | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-112 | LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE | DNA Labs, Inc. | 8d517ef2-3a1e-4393-9452-a4cd0f0a3bca | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-117 | ATROPA BELLADONNA AND SILICON DIOXIDE | DNA Labs, Inc. | 8bcce284-f8f3-4d62-a13e-b93c2c655a70 | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-109 | ATROPA BELLADONNA, VIROLA SEBIFERA RESIN, SILICON DIOXIDE, CALCIUM FLUORIDE, SODIUM BORATE, GOLD, BAPTISIA TINCTORIA ROOT, MERCURIC CYANIDE, CALOMEL, AND CORNUS RUGOSA WHOLE | DNA Labs, Inc. | 7758341d-e0be-487a-ba47-8847551231e1 | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-137 | APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, CALCIUM SULFIDE, RANCID BEEF, SULFUR, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIG | DNA Labs, Inc. | 240d03c0-957b-48e4-9bab-43f9e6b8fb42 | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-133 | CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATE | DNA Labs, Inc. | a250b7e9-7fd2-4cb0-82f3-baa089d17441 | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| Aurum Hypericum | AURUM HYPERICUM | Uriel Pharmacy Inc | be0da1f0-06a1-11df-8a39-0800200c9a66 | 2025-01-10 | Warnings | ETJ7Z6XBU4 |
| AM-9 | SPIGELIA ANTHELMIA, SILICON DIOXIDE, AND CORALLIUM RUBRUM WHOLE | DNA Labs, Inc. | d7a00f0b-de4c-4bff-b8e0-86a82bed8bb9 | 2025-01-09 | Warnings | ETJ7Z6XBU4 |
| N-8 | SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, AND BOS TAURUS OVARY | DNA Labs, Inc. | c25cdcb5-9469-48bb-b216-0a9d8d644e12 | 2025-01-09 | Warnings | ETJ7Z6XBU4 |
| N-23 | ANEMONE PULSATILLA, PHOSPHORUS, SILICON DIOXIDE, NITRIC ACID, ARSENIC TRIOXIDE, TOXICODENDRON PUBESCENS WHOLE, AND BOS TAURUS HYPOTHALAMUS | DNA Labs, Inc. | b6365b49-06fb-4692-96f7-a5097b70bc91 | 2025-01-09 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.