FDA.reportPublic FDA data

Lorbrena

Product NDC
0069-0227
11-digit product format
000690227
Labeler code
0069
Product ID
0069-0227_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
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
IngredientStrength
LORLATINIB25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOSP71S83EU
Rxcui2103169, 2103175, 2103177, 2103179

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed1e6b81-84a8-499f-9989-7148bd9c4c0bProduct name120190213

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0227-01Lorbrena30 in 1 BOTTLETABLET, FILM COATED3012
0069-0227-03Lorbrena120 in 1 BOTTLETABLET, FILM COATED12012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0227-01EA - Each0069-0227098106f0-32e6-4212-9d1c-2d60e2b108ae12018-12-13
0069-0227-03EA - Each0069-02276b451a5f-fd8d-4b1d-a4f9-c59d8fe2c41c12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0227LORBRENA (LORLATINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]9Current NDC, Legacy NDC, 2 package rows20250503_2b34d62d-e02a-4af3-bc0d-1571dd4ee76d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2103179LORBRENA 100 MG Oral TabletPSN2b34d62d-e02a-4af3-bc0d-1571dd4ee76d12
2103175LORBRENA 25 MG Oral TabletPSN2b34d62d-e02a-4af3-bc0d-1571dd4ee76d12
2103177lorlatinib 100 MG Oral TabletPSN2b34d62d-e02a-4af3-bc0d-1571dd4ee76d12
2103169lorlatinib 25 MG Oral TabletPSN2b34d62d-e02a-4af3-bc0d-1571dd4ee76d12
2103179lorlatinib 100 MG Oral Tablet [Lorbrena]SBD2b34d62d-e02a-4af3-bc0d-1571dd4ee76d12
2103175lorlatinib 25 MG Oral Tablet [Lorbrena]SBD2b34d62d-e02a-4af3-bc0d-1571dd4ee76d12
2103177lorlatinib 100 MG Oral TabletSCD2b34d62d-e02a-4af3-bc0d-1571dd4ee76d12
2103169lorlatinib 25 MG Oral TabletSCD2b34d62d-e02a-4af3-bc0d-1571dd4ee76d12
2103179Lorbrena 100 MG Oral TabletSY2b34d62d-e02a-4af3-bc0d-1571dd4ee76d12
2103175Lorbrena 25 MG Oral TabletSY2b34d62d-e02a-4af3-bc0d-1571dd4ee76d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-0227-010006902270130 TABLET, FILM COATED in 1 BOTTLE (0069-0227-01) 2018-11-190000-00-00NoNoCurrent
0069-0227-0300069022703120 TABLET, FILM COATED in 1 BOTTLE (0069-0227-03) 2025-01-03NoNoCurrent