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NDC 48818-0001-02 Folotyn 20 mg/mL Details
Folotyn 20 mg/mL
Folotyn is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acrotech Biopharma Inc. The primary component is PRALATREXATE.
MedlinePlus Drug Summary
Pralatrexate injection is used to treat peripheral T-cell lymphoma (PTCL; a form of cancer that begins in a certain type of cells in the immune system) that has not improved or that has come back after treatment with other medications. Pralatrexate injection has not been shown to help people who have lymphoma live longer. Pralatrexate injection is in a class of medications called folate analogue metabolic inhibitors. It works by killing cancer cells.
Related Packages: 48818-0001-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pralatrexate Injection
Product Information
| NDC | 48818-0001 |
|---|---|
| Product ID | 48818-001_6fd56180-47a2-4a9c-9f37-3088aa77b131 |
| Associated GPIs | 21300054002020 21300054002025 |
| GCN Sequence Number | 065649 |
| GCN Sequence Number Description | pralatrexate VIAL 20MG/ML(1) INTRAVEN |
| HIC3 | V1B |
| HIC3 Description | ANTINEOPLASTIC - ANTIMETABOLITES |
| GCN | 27663 |
| HICL Sequence Number | 036644 |
| HICL Sequence Number Description | PRALATREXATE |
| Brand/Generic | Brand |
| Proprietary Name | Folotyn |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | pralatrexate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/mL |
| Substance Name | PRALATREXATE |
| Labeler Name | Acrotech Biopharma Inc |
| Pharmaceutical Class | Folate Analog Metabolic Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022468 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 48818-0001-02 (48818000102)
| NDC Package Code | 48818-001-02 |
|---|---|
| Billing NDC | 48818000102 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (48818-001-02) / 2 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2009-09-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |