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NDC 70437-0240-18 Nerlynx 40 mg/1 Details
Nerlynx 40 mg/1
Nerlynx is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Puma Biotechnology, Inc.. The primary component is NERATINIB MALEATE.
MedlinePlus Drug Summary
Neratinib is used to treat a certain type of hormone receptor-positive breast cancer (breast cancer that depends on hormones such as estrogen to grow) in adults after treatment with trastuzumab (Herceptin) and other medications. Neratinib is used along with capecitabine (Xeloda) to treat a certain type of advanced hormone receptor-positive breast cancer or breast cancer that has spread to other parts of the body after treatment with at least two other medications. Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.
Related Packages: 70437-0240-18Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Neratinib
Product Information
| NDC | 70437-0240 |
|---|---|
| Product ID | 70437-240_0b2d093c-1603-e3dc-e063-6294a90a6f81 |
| Associated GPIs | 21533035100320 |
| GCN Sequence Number | 077566 |
| GCN Sequence Number Description | neratinib maleate TABLET 40 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 43613 |
| HICL Sequence Number | 044421 |
| HICL Sequence Number Description | NERATINIB MALEATE |
| Brand/Generic | Brand |
| Proprietary Name | Nerlynx |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | neratinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/1 |
| Substance Name | NERATINIB MALEATE |
| Labeler Name | Puma Biotechnology, Inc. |
| Pharmaceutical Class | Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208051 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70437-0240-18 (70437024018)
| NDC Package Code | 70437-240-18 |
|---|---|
| Billing NDC | 70437024018 |
| Package | 1 BOTTLE in 1 BOX (70437-240-18) / 180 TABLET in 1 BOTTLE |
| Marketing Start Date | 2017-07-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |