NDC 0069-0501

XELJANZ XR

Tofacitinib

XELJANZ XR is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Tofacitinib Citrate.

• Product ID: 0069-0501_109ebd67-7ce7-4c07-9101-3afd19cefd7b
• NDC: 0069-0501
• Product Type: Human Prescription Drug
• Proprietary Name: XELJANZ XR
• Generic Name: Tofacitinib
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-03-07
• Marketing Category: NDA / NDA
• Application Number: NDA208246
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: TOFACITINIB CITRATE
• Active Ingredient Strength: 11 mg/1
• Pharm Classes: Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0069-0501-30

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

• Marketing Start Date: 2016-03-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0501-14 [00069050114]

XELJANZ XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208246
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-03-07

NDC 0069-0501-30 [00069050130]

XELJANZ XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208246
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-03-07

Drug Details

Active Ingredients

Ingredient	Strength
TOFACITINIB CITRATE	11 mg/1

OpenFDA Data

• SPL SET ID: cf74ba2f-afc5-4baa-8594-979c889a5831
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • O1FF4DIV0D
• RxNorm Concept Unique ID - RxCUI:
  • 1357547
  • 1357541
  • 1741049
  • 2048566
  • 2048568
  • 1741046
• UPC Code:
  • 0300691001011
  • 0300690501307
  • 0300691002018

Pharmacological Class

• Janus Kinase Inhibitor [EPC]
• Janus Kinase Inhibitors [MoA]

NDC Crossover Matching brand name "XELJANZ XR" or generic name "Tofacitinib"

NDC	Brand Name	Generic Name
63539-501	XELJANZ XR	XELJANZ XR
63539-502	XELJANZ XR	XELJANZ XR
0069-0501	XELJANZ	tofacitinib
0069-0502	XELJANZ	tofacitinib
0069-1001	XELJANZ	tofacitinib
0069-1002	XELJANZ	tofacitinib