Fludarabine is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Fludarabine Phosphate.
| Product ID | 63323-192_40c40275-b5a2-4682-9c89-f92f55bb05fb |
| NDC | 63323-192 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fludarabine |
| Generic Name | Fludarabine Phosphate |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2007-11-16 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA078393 |
| Labeler Name | Fresenius Kabi USA, LLC |
| Substance Name | FLUDARABINE PHOSPHATE |
| Active Ingredient Strength | 25 mg/mL |
| Pharm Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2007-11-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA078393 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2007-11-16 |
| Ingredient | Strength |
|---|---|
| FLUDARABINE PHOSPHATE | 25 mg/mL |
| SPL SET ID: | cf5255cc-91fd-4132-973b-764dba142eae |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 63323-192 | Fludarabine | FLUDARABINE PHOSPHATE |
| 16729-131 | FLUDARABINE PHOSPHATE | FLUDARABINE |
| 24201-237 | fludarabine phosphate | fludarabine phosphate |
| 25021-237 | fludarabine phosphate | fludarabine phosphate |
| 25021-242 | Fludarabine Phosphate | Fludarabine Phosphate |
| 45963-609 | Fludarabine phosphate | Fludarabine phosphate |
| 45963-621 | Fludarabine phosphate | Fludarabine phosphate |
| 59923-604 | Fludarabine Phosphate | Fludarabine Phosphate |
| 61703-344 | Fludarabine Phosphate | FLUDARABINE PHOSPHATE |
| 66758-046 | Fludarabine Phosphate | Fludarabine Phosphate |