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NDC 00069-0231-01 Lorbrena 100 mg/1 Details
Lorbrena 100 mg/1
Lorbrena is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is LORLATINIB.
MedlinePlus Drug Summary
Lorlatinib is used to treat a certain type of non-small cell lung cancer (NSCLC) in adults that has spread to other parts of the body. Lorlatinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.
Related Packages: 00069-0231-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Lorlatinib
Product Information
| NDC | 00069-0231 |
|---|---|
| Product ID | 0069-0231_ea2ec3c5-caaa-4157-ac52-3c6adfff115e |
| Associated GPIs | 21530556000330 |
| GCN Sequence Number | 079229 |
| GCN Sequence Number Description | lorlatinib TABLET 100 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 45688 |
| HICL Sequence Number | 045448 |
| HICL Sequence Number Description | LORLATINIB |
| Brand/Generic | Brand |
| Proprietary Name | Lorbrena |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | lorlatinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | LORLATINIB |
| Labeler Name | Pfizer Laboratories Div Pfizer Inc |
| Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transpor |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA210868 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00069-0231-01 (00069023101)
| NDC Package Code | 0069-0231-01 |
|---|---|
| Billing NDC | 00069023101 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (0069-0231-01) |
| Marketing Start Date | 2018-11-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |