NDC 70518-2435-4 - Myrbetriq
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
- 70518-2435
- Requested NDC
- 70518-2435-4
- Package NDCs from labels
- 70518-2435-0, 70518-2435-2, 70518-2435-1, 70518-2435-4, 70518-2435-3
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2025-07-07
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Myrbetriq - REMEDYREPACK INC. | REMEDYREPACK INC. | 2025-07-07 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-2435 | MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.] | 9 | Legacy NDC | 20250316_f499d877-7699-424d-bd74-7c12d1bad129.zip |
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 |
|---|---|---|---|---|---|---|
| Mirabegron | MIRABEGRON | REMEDYREPACK INC. | 5f7a1758-8691-4e53-96d6-a01626ee8140 | 2026-09-03 | Warnings, Adverse reactions | 1300801 MVR3JL3B2V |
| MIRABEGRON | MIRABEGRON | REMEDYREPACK INC. | d0054db9-e38a-4786-be2c-996fa5b8f47d | 2026-05-22 | Warnings, Adverse reactions | 1300801 MVR3JL3B2V |
| Mirabegron | MIRABEGRON | Ascend Laboratories, LLC | 1c9022af-4841-4f3f-9737-1c5eef58e86b | 2026-05-22 | Warnings, Adverse reactions | 2541233 MVR3JL3B2V |
| Mirabegron | MIRABEGRON | REMEDYREPACK INC. | b71b939e-8cb1-492c-8311-28f75dc4c682 | 2026-04-27 | Warnings, Adverse reactions | 1300791 MVR3JL3B2V |
| Mirabegron | MIRABEGRON | Amneal Pharmaceuticals NY LLC | e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 | 2026-03-26 | Warnings, Adverse reactions | 1300801 1300791 MVR3JL3B2V |
| 4a194806-91f9-da7d-e063-6394a90a6591 | f499d877-7699-424d-bd74-7c12d1bad129 | 2026-02-05 | Warnings, Adverse reactions | f499d877-7699-424d-bd74-7c12d1bad129 | ||
| MIRABEGRON | MIRABEGRON | Lupin Pharmaceuticals, Inc. | d22d3d12-8466-46db-bc19-d13e87c6115c | 2025-12-24 | Warnings, Adverse reactions | 1300801 1300791 MVR3JL3B2V |
| Mirabegron | MIRABEGRON | Qilu Pharmaceutical Co., Ltd. | 98247602-29b9-4621-8eeb-519e40b883b9 | 2025-10-21 | Warnings, Adverse reactions | 1300801 1300791 MVR3JL3B2V |
| MIRABEGRON | MIRABEGRON | Bryant Ranch Prepack | 00826723-d25e-498a-b8d4-d17e5c14dda5 | 2025-09-26 | Warnings, Adverse reactions | 1300801 MVR3JL3B2V |
| MIRABEGRON | MIRABEGRON | Bryant Ranch Prepack | 1a7337a4-2901-4e65-b666-7623fadb78f2 | 2025-09-26 | Warnings, Adverse reactions | 1300801 MVR3JL3B2V |
| MIRABEGRON | MIRABEGRON | Bryant Ranch Prepack | 2965e083-b678-43b9-8e13-2efddc0daad0 | 2025-09-26 | Warnings, Adverse reactions | 1300791 MVR3JL3B2V |
| MIRABEGRON | MIRABEGRON | Bryant Ranch Prepack | 3bd73250-2b31-4b22-983b-15119846e697 | 2025-09-26 | Warnings, Adverse reactions | 1300791 MVR3JL3B2V |
| Mirabegron | MIRABEGRON | Zydus Lifesciences Limited | 461b2b94-205a-4860-9cb4-d30267ada9df | 2024-10-09 | Warnings, Adverse reactions | 1300801 1300791 MVR3JL3B2V |
| Mirabegron | MIRABEGRON | Zydus Pharmaceuticals (USA) Inc. | 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2 | 2024-10-09 | Warnings, Adverse reactions | 1300801 1300791 MVR3JL3B2V |
| Multi-Phenolic | MANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN, | Energique, Inc. | 492b412a-01cc-48f2-bcdc-6fffcc651963 | 2024-08-23 | Warnings | 1P9D0Z171K |
| Myrbetriq | MIRABEGRON | Astellas Pharma US, Inc. | ba9e9e15-e666-4c56-9271-2e24739cfa2d | 2024-08-01 | Warnings, Adverse reactions | NDA202611 0469-2602 2541233 1300803 1300801 2541237 1300797 1300791 fe8998d8-cf08-4e07-b966-33e8de20abf1 ba9e9e15-e666-4c56-9271-2e24739cfa2d MVR3JL3B2V |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | 1P9D0Z171K |
| AnubisMed | SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION | ANUBIS COSMETICS SL | e99d92c4-8768-9c0a-e053-2a95a90a609e | 2023-09-05 | Warnings | 1P9D0Z171K |
| Anubis Barcelona Vital Line | HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES | ANUBIS COSMETICS SL | ebe024f7-7c45-ad60-e053-2995a90a45d6 | 2023-09-01 | Warnings | 1P9D0Z171K |
| Anubis Barcelona Protective Line | ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE | ANUBIS COSMETICS SL | ec83846f-11c0-8f59-e053-2995a90ab9d2 | 2023-09-01 | Warnings | 1P9D0Z171K |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.