NDC 70518-4631-01 - Mirabegron
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
- 70518-4631
- Requested NDC
- 70518-4631-01
- Package NDCs from labels
- 70518-4631-1, 70518-4631-0, 70518-4631-01
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2026-04-27
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Mirabegron - REMEDYREPACK INC. | REMEDYREPACK INC. | 2026-04-27 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-4631-0 | Mirabegron | 50 in 1 BOX | TABLET, EXTENDED RELEASE | 50 | 1 | |
| 70518-4631-1 | Mirabegron | 1 in 1 POUCH | TABLET, EXTENDED RELEASE | 1 | 1 |
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 |
|---|---|---|---|---|---|---|
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 08b8003f-40be-3380-e063-6294a90a4f6b | 2025-09-05 | Warnings | 1K09F3G675 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | FSA Store Inc. | 3cd18f96-34f7-3f2c-e063-6294a90a3b7e | 2025-08-19 | Warnings | 1K09F3G675 |
| Ferrum rosatum Graphites | FERRUM ROSATUM GRAPHITES | Uriel Pharmacy Inc. | 1a4ca338-eada-4c0f-8bce-480244940c89 | 2025-06-27 | Warnings | 1K09F3G675 |
| Aquavit | AQUAVIT | Uriel Pharmacy Inc. | c1c0887a-c388-c737-e053-2a95a90a076c | 2025-06-06 | Warnings | 1K09F3G675 |
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 08b7eeeb-09ae-ffe6-e063-6294a90aba90 | 2025-05-07 | Warnings | 1K09F3G675 |
| RID Poison Ivy Rash Relief | CALAMINE AND ZINC OXIDE | Oystershell Consumer Health Inc. | 36c3af9a-2646-4427-e063-6394a90a2c5e | 2025-03-13 | Warnings | 1K09F3G675 |
| Calamine | FERRIC OXIDE RED | Preferred Pharmaceuticals Inc. | 326f3d80-c1bf-4cf0-a662-58e02ed7ee67 | 2025-02-12 | Warnings, Adverse reactions | 1K09F3G675 |
| Prunus Iron | PRUNUS IRON | Uriel Pharmacy Inc. | 091be588-b62e-4919-8e9e-3edb9792d319 | 2025-01-22 | Warnings | 1K09F3G675 |
| Ferrum Silicicum Urtica | FERRUM SILICICUM URTICA | Uriel Pharmacy Inc. | 09829ac4-c074-7315-e063-6394a90adf59 | 2025-01-07 | Warnings | 1K09F3G675 |
| Caladryl | FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE | Bausch Health US, LLC | 67d4fd42-9fed-4238-9f5a-c9403abbcf20 | 2024-10-17 | Warnings | 1K09F3G675 |
| Mirabegron | MIRABEGRON | Zydus Lifesciences Limited | 461b2b94-205a-4860-9cb4-d30267ada9df | 2024-10-09 | Warnings, Adverse reactions | ANDA209488 1300801 1300791 MVR3JL3B2V |
| Mirabegron | MIRABEGRON | Zydus Pharmaceuticals (USA) Inc. | 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2 | 2024-10-09 | Warnings, Adverse reactions | ANDA209488 70710-1159 1300801 1300791 df34c0c9-8528-4fd6-a408-e1d44da0f156 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2 MVR3JL3B2V |
| Calamine | CALAMINE AND ZINC OXIDE | Strategic Sourcing Services, LLC | 22173332-9d09-768c-e063-6394a90a94e1 | 2024-09-14 | Warnings | 1K09F3G675 |
| Myrbetriq | MIRABEGRON | Astellas Pharma US, Inc. | ba9e9e15-e666-4c56-9271-2e24739cfa2d | 2024-08-01 | Warnings, Adverse reactions | 1300801 1300791 MVR3JL3B2V |
| Calamine | FERRIC OXIDE RED | NuCare Pharmaceuticals,Inc. | 66e98554-e158-a519-e053-2a91aa0a6783 | 2024-06-06 | Warnings, Adverse reactions | 1K09F3G675 |
| Ferrum Oxydatum | FERRUM OXYDATUM | Hahnemann Laboratories, INC. | f8b52d3f-3fe2-a850-e053-6394a90a5d9f | 2023-04-06 | 1K09F3G675 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.