Lorbrena
- Product NDC
- 63539-927
- 11-digit product format
- 635390927
- Labeler code
- 63539
- Product ID
- 63539-927_810ce789-bff1-42b9-aef7-1f92f0dde727
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lorlatinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- U.S. Pharmaceuticals
- Application
- NDA210868
- Marketing category
- NDA
- Marketing start
- 2023-01-03
- Substance
- LORLATINIB
- Active strength
- 25 mg/1
- Pharmacologic classes
- 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 Transporter 3 Inhibitors [MoA], Organic Cation Transporter 1 Inhibitors [MoA], P-Glycoprotein Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lorbrena
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORLATINIB | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OSP71S83EU |
| Rxcui | 2103169, 2103175 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63539-927-01 | Lorbrena | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63539-927 | LORBRENA (LORLATINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 2 | Current NDC, 1 package rows | 20250109_004f93d7-a1cd-4b67-9207-31cdcb5c5976.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63539-927-01 | 63539092701 | 30 TABLET, FILM COATED in 1 BOTTLE (63539-927-01) | 2023-01-03 | Yes | No | Current |