Product NDC: | 23155-214 |
Proprietary Name: | Gemcitabine hydrochloride |
Non Proprietary Name: | Gemcitabine hydrochloride |
Active Ingredient(s): | 1 g/25mL & nbsp; Gemcitabine hydrochloride |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 23155-214 |
Labeler Name: | Heritage Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA202063 |
Marketing Category: | ANDA |
Start Marketing Date: | 20121022 |
Package NDC: | 23155-214-31 |
Package Description: | 1 VIAL, GLASS in 1 CARTON (23155-214-31) > 25 mL in 1 VIAL, GLASS |
NDC Code | 23155-214-31 |
Proprietary Name | Gemcitabine hydrochloride |
Package Description | 1 VIAL, GLASS in 1 CARTON (23155-214-31) > 25 mL in 1 VIAL, GLASS |
Product NDC | 23155-214 |
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 | 20121022 |
Marketing Category Name | ANDA |
Labeler Name | Heritage Pharmaceuticals Inc. |
Substance Name | GEMCITABINE HYDROCHLORIDE |
Strength Number | 1 |
Strength Unit | g/25mL |
Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |