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GEMCITABINE HYDROCHLORIDE
GEMCITABINE HYDROCHLORIDE - 63323-102-13 - (GEMCITABINE)
Drug Information of GEMCITABINE HYDROCHLORIDE
| Product NDC: | 63323-102 |
| Proprietary Name: | GEMCITABINE HYDROCHLORIDE |
| Non Proprietary Name: | GEMCITABINE |
| Active Ingredient(s): | 200 mg/5mL & nbsp; GEMCITABINE |
| 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: | 63323-102 |
| Labeler Name: | APP Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA090799 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20110726 |
Package Information of GEMCITABINE HYDROCHLORIDE
| Package NDC: | 63323-102-13 |
| Package Description: | 1 VIAL, SINGLE-USE in 1 BOX (63323-102-13) > 5 mL in 1 VIAL, SINGLE-USE |
NDC Information of GEMCITABINE HYDROCHLORIDE
| NDC Code | 63323-102-13 |
| Proprietary Name | GEMCITABINE HYDROCHLORIDE |
| Package Description | 1 VIAL, SINGLE-USE in 1 BOX (63323-102-13) > 5 mL in 1 VIAL, SINGLE-USE |
| Product NDC | 63323-102 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | GEMCITABINE |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20110726 |
| Marketing Category Name | ANDA |
| Labeler Name | APP Pharmaceuticals, LLC |
| Substance Name | GEMCITABINE HYDROCHLORIDE |
| Strength Number | 200 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
