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NDC 00517-4300-01 Paclitaxel 100 mg/20mL Details
Paclitaxel 100 mg/20mL
Paclitaxel is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by American Regent, Inc.. The primary component is PACLITAXEL.
MedlinePlus Drug Summary
Paclitaxel (with albumin) injection is used to treat breast cancer that has spread to other parts of the body and has not improved or worsened after treatment with other medications. Paclitaxel (with albumin) injection is also used in combination with other chemotherapy medications to treat non-small cell lung cancer (NSCLC). Paclitaxel (with albumin) injection is used in combination with gemcitabine (Gemzar) to treat cancer of the pancreas. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of cancer cells.
Related Packages: 00517-4300-01Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Paclitaxel (with albumin) Injection
Product Information
| NDC | 00517-4300 |
|---|---|
| Product ID | 0517-4300_2af4cfae-b569-4445-86f4-b11aba1a4538 |
| Associated GPIs | |
| GCN Sequence Number | 058624 |
| GCN Sequence Number Description | paclitaxel protein-bound VIAL 100 MG INTRAVEN |
| HIC3 | V1F |
| HIC3 Description | ANTINEOPLASTICS,MISCELLANEOUS |
| GCN | 24094 |
| HICL Sequence Number | 026856 |
| HICL Sequence Number Description | PACLITAXEL PROTEIN-BOUND |
| Brand/Generic | Generic |
| Proprietary Name | Paclitaxel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Paclitaxel |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/20mL |
| Substance Name | PACLITAXEL |
| Labeler Name | American Regent, Inc. |
| Pharmaceutical Class | Microtubule Inhibition [PE], Microtubule Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA211875 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00517-4300-01 (00517430001)
| NDC Package Code | 0517-4300-01 |
|---|---|
| Billing NDC | 00517430001 |
| Package | 1 VIAL in 1 CARTON (0517-4300-01) / 20 mL in 1 VIAL |
| Marketing Start Date | 2023-05-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |