Cibinqo

Product NDC
0069-0435
11-digit product format
000690435
Labeler code
0069
Product ID
0069-0435_d85989f4-41dc-4e3a-a0fa-759b68e1130c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abrocitinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA213871
Marketing category
NDA
Marketing start
2022-02-24
Substance
ABROCITINIB
Active strength
200 mg/1
Pharmacologic classes
Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cibinqo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABROCITINIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73SM5SF3OR
Rxcui2591481, 2591487, 2591489, 2591491, 2591493, 2591495

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
52f1c172-658d-4ec4-a093-ebfeee304338Product name120220928

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0435-30Cibinqo30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0435-30EA - Each0069-043538b55ee7-6f8b-4321-9631-3d83108d44dd12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0435CIBINQO (ABROCITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]6Current NDC, Legacy NDC, 1 package rows20250226_3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed258.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2591481abrocitinib 100 MG Oral TabletPSN3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591489abrocitinib 200 MG Oral TabletPSN3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591493abrocitinib 50 MG Oral TabletPSN3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591487Cibinqo 100 MG Oral TabletPSN3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591491Cibinqo 200 MG Oral TabletPSN3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591495Cibinqo 50 MG Oral TabletPSN3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591487abrocitinib 100 MG Oral Tablet [Cibinqo]SBD3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591491abrocitinib 200 MG Oral Tablet [Cibinqo]SBD3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591495abrocitinib 50 MG Oral Tablet [Cibinqo]SBD3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591481abrocitinib 100 MG Oral TabletSCD3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591489abrocitinib 200 MG Oral TabletSCD3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591493abrocitinib 50 MG Oral TabletSCD3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591487Cibinqo 100 MG Oral TabletSY3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591491Cibinqo 200 MG Oral TabletSY3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586
2591495Cibinqo 50 MG Oral TabletSY3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed2586

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-0435-300006904353030 TABLET, FILM COATED in 1 BOTTLE (0069-0435-30) 2022-02-240000-00-00NoNoCurrent