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NDC 55150-0393-01 AZACITIDINE 100 mg/4mL Details
AZACITIDINE 100 mg/4mL
AZACITIDINE is a INTRAVENOUS; SUBCUTANEOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eugia US LLC. The primary component is AZACITIDINE.
Product Information
NDC | 55150-0393 |
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Product ID | 55150-393_23509cbb-fa31-4369-98d1-2ce454828db9 |
Associated GPIs | |
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 | INTRAVENOUS; SUBCUTANEOUS |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/4mL |
Substance Name | AZACITIDINE |
Labeler Name | Eugia US LLC |
Pharmaceutical Class | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA215066 |
Listing Certified Through | 2024-12-31 |
Package
NDC 55150-0393-01 (55150039301)
NDC Package Code | 55150-393-01 |
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Billing NDC | 55150039301 |
Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-393-01) / 4 mL in 1 VIAL, SINGLE-DOSE |
Marketing Start Date | 2023-01-03 |
NDC Exclude Flag | N |
Pricing Information | N/A |