NDC 70436-217-38 - gadobutrol
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
- 70436-217
- Requested NDC
- 70436-217-38
- Package NDCs from labels
- 70436-217-38, 70436-217-80, 70436-217-78, 70436-217-50
- Manufacturer
- Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd.
- Effective date
- 2025-04-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| gadobutrol - Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd. | Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd. | 2025-04-17 | HUMAN PRESCRIPTION DRUG LABEL |
| gadobutrol - Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd. | Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd. | 2025-04-17 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70436-217-38 | gadobutrol | 65 mL in 1 VIAL, MULTI-DOSE | INJECTION | 65 | 1 | |
| 70436-217-50 | gadobutrol | 1 in 1 CARTON | INJECTION | 1 | 1 | |
| 70436-217-78 | gadobutrol | 65 mL in 1 VIAL, MULTI-DOSE | INJECTION | 65 | 1 | |
| 70436-217-80 | gadobutrol | 1 in 1 CARTON | INJECTION | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70436-217 | GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20250419_52fbda34-9974-4f9f-9749-6b17d0495b62.zip |
| 70436-217 | GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20250419_4af6ee2b-d039-497f-a8f0-bdf948e5f54e.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 |
|---|---|---|---|---|---|---|
| gadobutrol | GADOBUTROL | Zydus Pharmaceuticals USA Inc. | 4ea8ae43-22ca-40c0-be72-c91a321cafd1 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | 1BJ477IO2L |
| gadobutrol | GADOBUTROL | Viwit Pharmaceutical Co., Ltd. | 18c67a70-0c1f-46d4-a123-66080090b71b | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | 1BJ477IO2L |
| BM BM182 DROPS | HEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACID | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5423bde6-3e31-38b0-e063-6294a90afb2d | 2026-06-13 | Warnings | QTT17582CB |
| BM BM182 DROPS | HEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACID | BM Private Limited | 540d11e3-e4a1-0ca2-e063-6394a90a3c26 | 2026-06-12 | Warnings | QTT17582CB |
| THAM | TROMETHAMINE | Hospira, Inc. | 4af52118-c12b-4ad5-30bb-959848357e8a | 2026-05-27 | Warnings, Adverse reactions | 023C2WHX2V |
| Muriaticum acidum | HYDROCHLORIC ACID | Boiron | 8643bc58-bb0e-5c79-e053-2991aa0a02ae | 2026-05-19 | Warnings | QTT17582CB |
| Gadavist | GADOBUTROL | Bayer HealthCare Pharmaceuticals Inc. | 3c5101a0-0c7e-4078-8dc3-a57beb9a0e92 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 1BJ477IO2L |
| Gadavist | GADOBUTROL | Bayer HealthCare Pharmaceuticals Inc. | b7afe34d-b70f-41a5-b89c-561bdf29f046 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 1BJ477IO2L |
| Gadavist | GADOBUTROL | Bayer HealthCare Pharmaceuticals Inc. | bd28560f-de4d-4140-874e-31df823f4dbb | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 1BJ477IO2L |
| Skin Irritations and Itch Relief | AGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS. | King Bio Inc. | d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd | 2026-03-10 | Warnings | QTT17582CB |
| Endotoxin Terrain Drops 2143 | ENDOTOXIN TERRAIN DROPS | Professional Complementary Health Formulas | 58842566-005a-48b5-973d-20cde2fbd701 | 2026-01-08 | Warnings | QTT17582CB |
| Abdominal Pain Drops 2051 | ABDOMINAL PAIN DROPS | Professional Complementary Health Formulas | f1b1dde6-bb37-4774-a58c-b4f648f9c2b5 | 2026-01-08 | Warnings | QTT17582CB |
| Tromethamine | TROMETHAMINE | MILLA PHARMACEUTICALS INC. | 082b1104-502b-47af-95bf-0dbf2422990e | 2026-01-07 | Warnings, Adverse reactions | 023C2WHX2V |
| Hemorrhoid | AESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHUR | Natural Creations, Inc | db1b3aef-ba92-417c-b6f6-58e950ed4214 | 2025-12-16 | Warnings | QTT17582CB |
| Gadobutrol | GADOBUTROL | Fresenius Kabi USA, LLC | c0dd1618-0bb3-4974-846b-e5afc2311ae6 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | 1BJ477IO2L |
| Gadobutrol | GADOBUTROL | Fresenius Kabi USA, LLC | 007696d0-4b62-4937-9640-4ad619504df4 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 1BJ477IO2L |
| gadobutrol | GADOBUTROL | Slate Run Pharmaceuticals, LLC | 52fbda34-9974-4f9f-9749-6b17d0495b62 | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | ANDA217480 70436-216-77 70436-217-50 70436-217-78 70436-216-51 70436-216 70436-217 3304ec39-b300-eb0a-e063-6394a90a1cd1 52fbda34-9974-4f9f-9749-6b17d0495b62 1BJ477IO2L |
| gadobutrol | GADOBUTROL | Slate Run Pharmaceuticals, LLC | 832e0ae1-4fe1-4dff-9978-c9200bcebb55 | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | ANDA217480 1BJ477IO2L |
| gadobutrol | GADOBUTROL | Slate Run Pharmaceuticals, LLC | 4af6ee2b-d039-497f-a8f0-bdf948e5f54e | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | ANDA217480 70436-216-36 70436-217-38 70436-216-81 70436-217-80 70436-216 70436-217 70436021738 3304f9cc-5bf9-dd3e-e063-6394a90a43c9 4af6ee2b-d039-497f-a8f0-bdf948e5f54e 1BJ477IO2L |
| Bestmade Natural Products BM182 Pellets | GRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACID | Bestmade Natural Products | 3242e013-2952-2b56-e063-6294a90a1693 | 2025-04-08 | Warnings | QTT17582CB |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.