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 |
|---|---|---|---|---|---|---|
| Baby Nighttime Oral Pain Relief | ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDE | Hyland' Inc. | 58ef86b7-5b38-1591-e053-2991aa0aa53e | 2025-03-17 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products Tooth Remineralization Remedy | CALCAREA PHOSPHORICA, CALCAREA FLUORICA, SILICEA | Bestmade Natural Products | 304ca377-573a-6622-e063-6394a90a3fcc | 2025-03-14 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BIO18 Lactose Free | CALC FLUOR, SILICEA, CALC SULPH | Bestmade Natural Products | 3038634b-ae79-fe22-e063-6294a90a438e | 2025-03-13 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BIO25 Lactose Free | NAT PHOS, NAT SULPH, SILICEA | Bestmade Natural Products | 303acd47-e033-1563-e063-6394a90ae38e | 2025-03-13 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BIO28 Lactose Free | CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA | Bestmade Natural Products | 303b4d92-9f75-38a5-e063-6294a90ae93d | 2025-03-13 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BIO4 Lactose Free | CALC FLUOR, KALI MUR, NAT MUR, SILICEA | Bestmade Natural Products | 30220aca-e052-95f3-e063-6294a90a9cea | 2025-03-12 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BIO18 | CALC FLUOR, SILICEA, CALC SULPH | Bestmade Natural Products | 300ce604-e2c0-e23f-e063-6394a90a6780 | 2025-03-11 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BIO25 | NAT PHOS, NAT SULPH, SILICEA | Bestmade Natural Products | 300e3d46-1fc3-659e-e063-6394a90ade25 | 2025-03-11 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BIO28 | CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA | Bestmade Natural Products | 300ead4c-6937-d597-e063-6394a90ad6bb | 2025-03-11 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BIO4 | CALC FLUOR, KALI MUR, NAT MUR, SILICEA | Bestmade Natural Products | 2ffcffd8-94ba-3a4c-e063-6394a90a24ee | 2025-03-10 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products Silicea | SILICEA | Bestmade Natural Products | 2fabb037-5f94-cbb4-e063-6294a90a7b83 | 2025-03-06 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM231 | ABROTANUM, ANTI IOD, ARSENIC IOD, BARYTA CARB, CALC PHOS, FERR MET, KALI IOD, SILICEA | Bestmade Natural Products | 2f81507c-b5b0-a976-e063-6394a90a869e | 2025-03-04 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM237 | BELLADONA, BARYTA CARB, HEPAR SULPH, KALI BICH, MERC IOD FLAV, MERC IOD RUB, SILICEA | Bestmade Natural Products | 2f82f2c4-a549-9e17-e063-6394a90aea81 | 2025-03-04 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM214 | CARBO VEG, FERRUM PHOS, SILICA, KALI CARB, CALC PHOS, NAT MUR | Bestmade Natural Products | 2f6e08d8-a6f9-c049-e063-6394a90a6df1 | 2025-03-03 | Warnings | ETJ7Z6XBU4 |
| YVTYVT MICRODERMABRASION FACIAL SCRUB | YVTYVT MICRODERMABRASION FACIAL SCRUB | Beijing JUNGE Technology Co., Ltd. | 2f30fc45-42e2-c766-e063-6394a90a8d68 | 2025-02-28 | Warnings | OP1R32D61U |
| Silicea | SILICON DIOXIDE | Washington Homeopathic Products | 2ee71a08-f69b-e2ef-e063-6394a90ab990 | 2025-02-24 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM186 | ARNICA, FERR. PHOS, IGNATIA, SILICA, HYPERICUM | Bestmade Natural Products | 2e9437ae-59fa-c646-e063-6294a90ac0f6 | 2025-02-20 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM173 | ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA UREN | Bestmade Natural Products | 2e7de086-a4c1-ae9e-e063-6394a90aa5f5 | 2025-02-19 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BM146 | ACID SULPH, APIS MELL, ARNICA MONT, CALENDULA OFF, HAMAMELIS, IODIUM, LYCOPODIUM, SILICEA | Bestmade Natural Products | 2e69161f-e4e2-a5cc-e063-6394a90a476f | 2025-02-18 | Warnings | ETJ7Z6XBU4 |
| Aurum Hypericum | AURUM HYPERICUM | Uriel Pharmacy, Inc | 2df4f968-af1d-82f1-e063-6294a90a65be | 2025-02-12 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.