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 Bio28 | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 3e85a931-57f6-2a55-e063-6294a90ac180 | 2025-12-02 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BIO28 | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA: Bestmade Natural Products Micro | 3e46ee90-2c2c-0a70-e063-6294a90a576a | 2025-12-02 | Warnings | ETJ7Z6XBU4 |
| BM Silicea | SILICEA | BM Private Limited | 37b0535d-6bcf-2d40-e063-6294a90a2a8e | 2025-12-02 | Warnings | ETJ7Z6XBU4 |
| BM Silicea Icing Sugar | SILICEA ICING SUGAR | BM Private Limited | 37c1f61d-dfe4-9dcf-e063-6394a90aceb1 | 2025-12-02 | Warnings | ETJ7Z6XBU4 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Chartwell RX, LLC | b38f43c8-d02d-4aee-ab23-e898cbfadfbc | 2025-12-02 | Warnings, Adverse reactions | 317110 311196 353538 LX1OH63030 |
| OUHOE Biotin With Hydrolyzed Collagen | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 43138915-5fe1-6e32-e063-6294a90abefa | 2025-11-27 | Warnings | ZF94AP8MEY |
| HOUKEA Pure Magnesium Oil | GLYCERIN | Guangzhou Houkea Biotechnology Co., Ltd. | 33fc279b-3b15-973d-e063-6394a90aad3e | 2025-11-27 | Warnings | ZF94AP8MEY |
| Bambusa Pulsatilla | BAMBUSA PULSATILLA | Uriel Pharmacy Inc. | 0776c3be-088d-422c-9c12-08fcaae823e1 | 2025-11-26 | 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. | b597504a-c667-225c-e053-2a95a90ac704 | 2025-11-25 | Warnings | ETJ7Z6XBU4 |
| DOCTRUST ONE S Tooth | SODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATE | DONG IL PHARMS CO.,LTD | 4476923a-48f1-9f72-e063-6394a90a0708 | 2025-11-25 | Warnings | ETJ7Z6XBU4 |
| DOCTRUST K Tooth | SILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATE | DONG IL PHARMS CO.,LTD | 44768dd1-b132-c33b-e063-6294a90accd4 | 2025-11-25 | Warnings | ETJ7Z6XBU4 |
| Gout Pain Management | ARNICA MONTANA, URTICA URENS, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAF | Forces of Nature | 9276fe9c-d9a2-4cef-986c-5d7d39f2d6a1 | 2025-11-25 | Warnings | ETJ7Z6XBU4 |
| Natural Eyes Floaters Relief | CHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEA | TRP Company | 445dc831-195e-4b25-e063-6294a90a6efd | 2025-11-24 | Warnings | ETJ7Z6XBU4 |
| Lymph HP | ACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CAUSTICUM, ECHINACEA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LOBELIA INFLATA, LOMATIUM DISSECTUM, LUNG, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, SYMPHYTUM OFFICINALE | Energique, Inc. | 17aa9d9c-3d32-4963-91db-d1e96717e7ad | 2025-11-24 | Warnings | ETJ7Z6XBU4 |
| CONSTIPATION | MAGNESIA CARBONICA, MAGNESIA MURIATICA, AESCULUS HIPPOCASTANUM, ALUMEN, ALUMINA, BRYONIA ALBA, NUX VOMICA, SILICEA | Natural Creations, Inc. | d2e24f5a-747b-4d62-bbdf-16c0e43becdb | 2025-11-21 | Warnings | ETJ7Z6XBU4 |
| Pneumo Sarcode | TEUCRIUM SCORODONIA, ARSENICUM IODATUM, LUNG (BOVINE), CALCAREA PHOSPHORICA, STANNUM METALLICUM, CARBO VEGETABILIS, PHELLANDRIUM AQUATICUM, SILICEA, SULPHUR | Nutritional Specialties, Inc. | c3a7cf75-723e-4fb9-8ff8-ae8f73a0900d | 2025-11-20 | Warnings | ETJ7Z6XBU4 |
| Gelusil | ALUMINA, MAGNESIA, SIMETHICONE | WellSpring Pharmaceutical Corporation | 92fbeec1-1562-40f3-9734-41f133d494f9 | 2025-11-20 | Warnings | ETJ7Z6XBU4 |
| Cold | BAPTISIA TINCTORIA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, LOMATIUM DISSECTUM, PUERARIA LOBATA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ALLIUM CEPA, ARSENICUM IODATUM, BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, KALI MURIATICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, SILICEA | Natural Creations, Inc | c45d1d8f-24be-4c13-8c4b-388962421415 | 2025-11-20 | Warnings | ETJ7Z6XBU4 |
| Endometrium Argentum | ENDOMETRIUM ARGENTUM | Uriel Pharmacy Inc. | 5590d577-3a98-49b8-bb12-ddd7f5cfd080 | 2025-11-19 | Warnings | ETJ7Z6XBU4 |
| Dizziness HP | CALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, TABACUM, | Energique, Inc. | 0bf53ecc-c2ad-40b5-b921-7c10a1b00626 | 2025-11-19 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.