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GEMCITABINE
GEMCITABINE - 47335-153-40 - (GEMCITABINE HYDROCHLORIDE)
Drug Information of GEMCITABINE
| Product NDC: | 47335-153 |
| Proprietary Name: | GEMCITABINE |
| Non Proprietary Name: | GEMCITABINE HYDROCHLORIDE |
| Active Ingredient(s): | 200 mg/5mL & nbsp; GEMCITABINE HYDROCHLORIDE |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of GEMCITABINE
| Product NDC: | 47335-153 |
| Labeler Name: | Sun Pharma Global FZE |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078433 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20110725 |
Package Information of GEMCITABINE
| Package NDC: | 47335-153-40 |
| Package Description: | 1 VIAL, SINGLE-USE in 1 CARTON (47335-153-40) > 5 mL in 1 VIAL, SINGLE-USE |
NDC Information of GEMCITABINE
| NDC Code | 47335-153-40 |
| Proprietary Name | GEMCITABINE |
| Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (47335-153-40) > 5 mL in 1 VIAL, SINGLE-USE |
| Product NDC | 47335-153 |
| 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 | 20110725 |
| Marketing Category Name | ANDA |
| Labeler Name | Sun Pharma Global FZE |
| Substance Name | GEMCITABINE HYDROCHLORIDE |
| Strength Number | 200 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
