xeljanz xr

Generic: tofacitinib

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xeljanz xr
Generic Name tofacitinib
Labeler pfizer laboratories div pfizer inc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tofacitinib citrate 11 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0501
Product ID 0069-0501_60d5a945-0cec-4730-854b-d675fc116621
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208246
Listing Expiration 2027-12-31
Marketing Start 2016-03-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00690501
Hyphenated Format 0069-0501

Supplemental Identifiers

RxCUI
1357541 1357547 1741046 1741049 2048566 2048568 2273113 2273115 2478433 2478437
UPC
0300691002018 0300691001011
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 xr (source: ndc)
Generic Name tofacitinib (source: ndc)
Application Number NDA208246 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 11 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0501-30)
source: ndc

Packages (1)

0069-0501-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0501-30)

Ingredients (1)

tofacitinib citrate (11 mg/1)

Linked Drug Pages (1)

XELJANZ XR, XELJANZ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "60d5a945-0cec-4730-854b-d675fc116621", "openfda": {"upc": ["0300691002018", "0300691001011"], "unii": ["O1FF4DIV0D"], "rxcui": ["1357541", "1357547", "1741046", "1741049", "2048566", "2048568", "2273113", "2273115", "2478433", "2478437"], "spl_set_id": ["cf74ba2f-afc5-4baa-8594-979c889a5831"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0501-30)", "package_ndc": "0069-0501-30", "marketing_start_date": "20160307"}], "brand_name": "XELJANZ XR", "product_id": "0069-0501_60d5a945-0cec-4730-854b-d675fc116621", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Janus Kinase Inhibitor [EPC]", "Janus Kinase Inhibitors [MoA]"], "product_ndc": "0069-0501", "generic_name": "tofacitinib", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XELJANZ", "brand_name_suffix": "XR", "active_ingredients": [{"name": "TOFACITINIB CITRATE", "strength": "11 mg/1"}], "application_number": "NDA208246", "marketing_category": "NDA", "marketing_start_date": "20160307", "listing_expiration_date": "20271231"}