xeljanz

Generic: tofacitinib

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xeljanz
Generic Name tofacitinib
Labeler u.s. pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tofacitinib citrate 5 mg/1

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-012
Product ID 63539-012_c422393a-1e5c-46d2-81df-3d05818bf50e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203214
Listing Expiration 2027-12-31
Marketing Start 2012-11-08

Pharmacologic Class

Classes
janus kinase inhibitor [epc] janus kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539012
Hyphenated Format 63539-012

Supplemental Identifiers

RxCUI
1357541 1357547 1741046 1741049 2048566 2048568 2273113 2273115 2478433 2478437
UNII
O1FF4DIV0D

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xeljanz (source: ndc)
Generic Name tofacitinib (source: ndc)
Application Number NDA203214 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (63539-012-02)
source: ndc

Packages (1)

63539-012-02 60 TABLET, FILM COATED in 1 BOTTLE (63539-012-02)

Ingredients (1)

tofacitinib citrate (5 mg/1)

Linked Drug Pages (1)

XELJANZ, XELJANZ XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c422393a-1e5c-46d2-81df-3d05818bf50e", "openfda": {"unii": ["O1FF4DIV0D"], "rxcui": ["1357541", "1357547", "1741046", "1741049", "2048566", "2048568", "2273113", "2273115", "2478433", "2478437"], "spl_set_id": ["68e3d6b2-7838-4d2d-a417-09d919b43e13"], "manufacturer_name": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63539-012-02)", "package_ndc": "63539-012-02", "marketing_start_date": "20121108"}], "brand_name": "XELJANZ", "product_id": "63539-012_c422393a-1e5c-46d2-81df-3d05818bf50e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Janus Kinase Inhibitor [EPC]", "Janus Kinase Inhibitors [MoA]"], "product_ndc": "63539-012", "generic_name": "tofacitinib", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XELJANZ", "active_ingredients": [{"name": "TOFACITINIB CITRATE", "strength": "5 mg/1"}], "application_number": "NDA203214", "marketing_category": "NDA", "marketing_start_date": "20121108", "listing_expiration_date": "20271231"}