Product NDC: | 0409-0187 |
Proprietary Name: | GEMCITABINE |
Non Proprietary Name: | GEMCITABINE HYDROCHLORIDE |
Active Ingredient(s): | 38 mg/mL & nbsp; GEMCITABINE HYDROCHLORIDE |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0409-0187 |
Labeler Name: | Hospira, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA079183 |
Marketing Category: | ANDA |
Start Marketing Date: | 20101115 |
Package NDC: | 0409-0187-01 |
Package Description: | 1 VIAL, SINGLE-USE in 1 CARTON (0409-0187-01) > 52.6 mL in 1 VIAL, SINGLE-USE |
NDC Code | 0409-0187-01 |
Proprietary Name | GEMCITABINE |
Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (0409-0187-01) > 52.6 mL in 1 VIAL, SINGLE-USE |
Product NDC | 0409-0187 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | GEMCITABINE HYDROCHLORIDE |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20101115 |
Marketing Category Name | ANDA |
Labeler Name | Hospira, Inc. |
Substance Name | GEMCITABINE HYDROCHLORIDE |
Strength Number | 38 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |