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 SOLUTION
Routes
ORAL
Active Ingredients

tofacitinib citrate 1 mg/mL

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-029
Product ID 63539-029_c422393a-1e5c-46d2-81df-3d05818bf50e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213082
Listing Expiration 2027-12-31
Marketing Start 2021-02-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539029
Hyphenated Format 63539-029

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 NDA213082 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63539-029-02) / 240 mL in 1 BOTTLE (63539-029-01)
source: ndc

Packages (1)

63539-029-02 1 BOTTLE in 1 CARTON (63539-029-02) / 240 mL in 1 BOTTLE (63539-029-01)

Ingredients (1)

tofacitinib citrate (1 mg/mL)

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": "1 BOTTLE in 1 CARTON (63539-029-02)  / 240 mL in 1 BOTTLE (63539-029-01)", "package_ndc": "63539-029-02", "marketing_start_date": "20210208"}], "brand_name": "XELJANZ", "product_id": "63539-029_c422393a-1e5c-46d2-81df-3d05818bf50e", "dosage_form": "SOLUTION", "pharm_class": ["Janus Kinase Inhibitor [EPC]", "Janus Kinase Inhibitors [MoA]"], "product_ndc": "63539-029", "generic_name": "tofacitinib", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XELJANZ", "active_ingredients": [{"name": "TOFACITINIB CITRATE", "strength": "1 mg/mL"}], "application_number": "NDA213082", "marketing_category": "NDA", "marketing_start_date": "20210208", "listing_expiration_date": "20271231"}