Lorbrena
- Product NDC
- 0069-0231
- 11-digit product format
- 000690231
- Labeler code
- 0069
- Product ID
- 0069-0231_fa9433bd-5ed2-47c3-84cb-f751c1345f81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lorlatinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA210868
- Marketing category
- NDA
- Marketing start
- 2018-11-19
- Substance
- LORLATINIB
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OSP71S83EU |
| Rxcui | 2103169, 2103175, 2103177, 2103179 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0069-0231-01 | Lorbrena | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0069-0231 | LORBRENA (LORLATINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20250503_2b34d62d-e02a-4af3-bc0d-1571dd4ee76d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0069-0231-01 | 00069023101 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-0231-01) | 2018-11-19 | 0000-00-00 | No | No | Current |