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Gemcitabine Hydrochloride
Gemcitabine Hydrochloride - 16729-092-03 - (Gemcitabine Hydrochloride)
Drug Information of Gemcitabine Hydrochloride
| Product NDC: | 16729-092 |
| Proprietary Name: | Gemcitabine Hydrochloride |
| 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 Hydrochloride
| Product NDC: | 16729-092 |
| Labeler Name: | Accord Healthcare, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA091594 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20110725 |
Package Information of Gemcitabine Hydrochloride
| Package NDC: | 16729-092-03 |
| Package Description: | 1 VIAL in 1 CARTON (16729-092-03) > 5 mL in 1 VIAL |
NDC Information of Gemcitabine Hydrochloride
| NDC Code | 16729-092-03 |
| Proprietary Name | Gemcitabine Hydrochloride |
| Package Description | 1 VIAL in 1 CARTON (16729-092-03) > 5 mL in 1 VIAL |
| Product NDC | 16729-092 |
| 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 | Accord Healthcare, Inc. |
| Substance Name | GEMCITABINE HYDROCHLORIDE |
| Strength Number | 200 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
