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NDC 50742-0497-53 GEMCITABINE 38 mg/mL Details
GEMCITABINE 38 mg/mL
GEMCITABINE is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ingenus Pharmaceuticals, LLC. The primary component is GEMCITABINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Gemcitabine is used in combination with carboplatin to treat ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed) that returned at least 6 months after finishing a previous treatment. It also used in combination with paclitaxel (Abraxane, Taxol) to treat breast cancer that has not improved or that has worsened after treatment with other medications. Gemcitabine is used in combination with cisplatin to treat a type of lung cancer (non-small cell lung cancer; NSCLC) that has spread to other parts of the body and cannot be treated with surgery. Gemcitabine is also used to treat pancreatic cancer that has spread to other parts of the body and has not improved or worsened after treatment with another medication. Gemcitabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in your body.
Related Packages: 50742-0497-53Last Updated: 04/14/2024
MedLinePlus Full Drug Details: Gemcitabine Injection
Product Information
| NDC | 50742-0497 |
|---|---|
| Product ID | 50742-497_fbfd32c8-27e6-4f09-a09c-5fce401b87c1 |
| Associated GPIs | |
| GCN Sequence Number | 068085 |
| GCN Sequence Number Description | gemcitabine HCl VIAL 2 G/52.6ML INTRAVEN |
| HIC3 | V1B |
| HIC3 Description | ANTINEOPLASTIC - ANTIMETABOLITES |
| GCN | 30777 |
| HICL Sequence Number | 010798 |
| HICL Sequence Number Description | GEMCITABINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | GEMCITABINE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | gemcitabine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 38 |
| Active Ingredient Units | mg/mL |
| Substance Name | GEMCITABINE HYDROCHLORIDE |
| Labeler Name | Ingenus Pharmaceuticals, LLC |
| Pharmaceutical Class | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210383 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50742-0497-53 (50742049753)
| NDC Package Code | 50742-497-53 |
|---|---|
| Billing NDC | 50742049753 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-497-53) / 52.6 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2023-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |