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NDC 51991-0797-98 Azacitidine 100 mg/50mL Details
Azacitidine 100 mg/50mL
Azacitidine is a SUBCUTANEOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is AZACITIDINE.
MedlinePlus Drug Summary
Azacitidine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow.
Related Packages: 51991-0797-98Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Azacitidine Injection
Product Information
| NDC | 51991-0797 |
|---|---|
| Product ID | 51991-797_1ba11f6a-c960-4e56-9f71-fdc972d990db |
| Associated GPIs | 21300003001920 |
| GCN Sequence Number | 054660 |
| GCN Sequence Number Description | azacitidine VIAL 100 MG INJECTION |
| HIC3 | V1B |
| HIC3 Description | ANTINEOPLASTIC - ANTIMETABOLITES |
| GCN | 22663 |
| HICL Sequence Number | 026361 |
| HICL Sequence Number Description | AZACITIDINE |
| Brand/Generic | Generic |
| Proprietary Name | Azacitidine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Azacitidine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/50mL |
| Substance Name | AZACITIDINE |
| Labeler Name | Breckenridge Pharmaceutical, Inc. |
| Pharmaceutical Class | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207234 |
| Listing Certified Through | n/a |
Package
NDC 51991-0797-98 (51991079798)
| NDC Package Code | 51991-797-98 |
|---|---|
| Billing NDC | 51991079798 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (51991-797-98) / 50 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2017-08-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |