63539-236 NDC - CIBINQO (ABROCITINIB)

Drug Information

Product NDC: 63539-236
Proprietary Name: CIBINQO
Non Proprietary Name: abrocitinib
Active Ingredient(s): 50 mg/1 ABROCITINIB
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Pharmacy Class(es): Janus Kinase Inhibitor [EPC]; Janus Kinase Inhibitors [MoA]; P-Glycoprotein Inhibitors [MoA]

Labeler Information

Field Name	Field Value
Labeler Name:	U.S. Pharmaceuticals
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	NDA213871
Marketing Category:	NDA
Start Marketing Date:	2/24/2022

Package Information

No.	Package Code	Package Description	Billing Unit
1	63539-236-14	14 TABLET, FILM COATED in 1 BOTTLE (63539-236-14)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	63539-236	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	CIBINQO	This is the date that the labeler indicates was the start of its marketing of the drug product.
NON PROPRIETARY NAME	abrocitinib	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
DOSAGE FORM NAME	TABLET, FILM COATED	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ROUTE NAME	ORAL	Name of Company corresponding to the labeler code segment of the Product NDC.
START MARKETING DATE	2/24/2022	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBER	NDA213871	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	U.S. Pharmaceuticals	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ABROCITINIB	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	50
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]

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This page was last updated on: 11/21/2025

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