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NDC 63323-0450-50 Pemetrexed 500 mg/20mL Details
Pemetrexed 500 mg/20mL
Pemetrexed is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is PEMETREXED DISODIUM.
MedlinePlus Drug Summary
Pemetrexed injection is used in combination with other chemotherapy medications as a first treatment for a certain type of non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body. Pemetrexed injection is also used alone to treat NSCLC as ongoing treatment in people who have already received certain chemotherapy medications and whose cancer has not worsened and in people who could not be treated successfully with other chemotherapy medications. Pemetrexed injection is also in combination with another chemotherapy medication as a first treatment for malignant pleural mesothelioma (a type of cancer that affects the inside lining of the chest cavity) in people who cannot be treated with surgery. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help cancer cells multiply.
Related Packages: 63323-0450-50Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pemetrexed Injection
Product Information
| NDC | 63323-0450 |
|---|---|
| Product ID | 63323-450_d2e3def4-a49f-4810-ab4e-f7edebefa210 |
| Associated GPIs | 21300053102120 |
| GCN Sequence Number | 053600 |
| GCN Sequence Number Description | pemetrexed disodium VIAL 500 MG INTRAVEN |
| HIC3 | V1B |
| HIC3 Description | ANTINEOPLASTIC - ANTIMETABOLITES |
| GCN | 21179 |
| HICL Sequence Number | 025905 |
| HICL Sequence Number Description | PEMETREXED DISODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Pemetrexed |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | PEMETREXED DISODIUM |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/20mL |
| Substance Name | PEMETREXED DISODIUM |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090384 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 63323-0450-50 (63323045050)
| NDC Package Code | 63323-450-50 |
|---|---|
| Billing NDC | 63323045050 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (63323-450-50) / 20 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2022-05-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |