Azacitidine is a Intravenous; Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Azacitidine.
| Product ID | 63323-771_a2c71cff-4528-4f4c-b1b2-90483b5fc1f6 |
| NDC | 63323-771 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Azacitidine |
| Generic Name | Azacitidine |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS; SUBCUTANEOUS |
| Marketing Start Date | 2017-03-16 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207518 |
| Labeler Name | Fresenius Kabi USA, LLC |
| Substance Name | AZACITIDINE |
| Active Ingredient Strength | 100 mg/30mL |
| Pharm Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2017-03-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA207518 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-03-16 |
| Ingredient | Strength |
|---|---|
| AZACITIDINE | 100 mg/30mL |
| SPL SET ID: | 3b594aba-e798-4105-b801-0b0d970747c1 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9606 | Azacitidine | Azacitidine |
| 0591-2897 | Azacitidine | Azacitidine |
| 0781-3253 | Azacitidine | azacitidine |
| 0781-9253 | Azacitidine | azacitidine |
| 16714-578 | Azacitidine | Azacitidine |
| 16714-777 | Azacitidine | Azacitidine |
| 16714-927 | Azacitidine | Azacitidine |
| 16729-306 | Azacitidine | Azacitidine |
| 43598-143 | Azacitidine | Azacitidine |
| 43598-305 | Azacitidine | Azacitidine |
| 43598-465 | Azacitidine | Azacitidine |
| 43598-678 | AZACITIDINE | AZACITIDINE |
| 43817-906 | Azacitidine | Azacitidine |
| 51991-797 | Azacitidine | Azacitidine |
| 55150-393 | AZACITIDINE | AZACITIDINE |
| 68001-313 | Azacitidine | Azacitidine |
| 69097-368 | Azacitidine | Azacitidine |
| 72485-201 | AZACITIDINE | AZACITIDINE |
| 63323-771 | Azacitidine | Azacitidine |
| 63759-0003 | AZACITIDINE | AZACITIDINE |
| 64679-096 | AZACITIDINE | AZACITIDINE |
| 67457-254 | Azacitidine | Azacitidine |
| 72606-558 | AZACITIDINE | AZACITIDINE |
| 71288-115 | Azacitidine | Azacitidine |
| 59572-730 | ONUREG | azacitidine |
| 59572-740 | ONUREG | azacitidine |
| 59572-102 | VIDAZA | azacitidine |