NDC 0069-1002

XELJANZ

Tofacitinib

XELJANZ is a Oral Tablet, Film Coated 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: 0069-1002_109ebd67-7ce7-4c07-9101-3afd19cefd7b
• NDC: 0069-1002
• Product Type: Human Prescription Drug
• Proprietary Name: XELJANZ
• Generic Name: Tofacitinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-02
• Marketing Category: NDA / NDA
• Application Number: NDA203214
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: TOFACITINIB CITRATE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0069-1002-01

60 TABLET, FILM COATED in 1 BOTTLE (0069-1002-01)

• Marketing Start Date: 2018-07-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-1002-01 [00069100201]

XELJANZ TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA203214
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-02

NDC 0069-1002-02 [00069100202]

XELJANZ TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA203214
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-02

NDC 0069-1002-03 [00069100203]

XELJANZ TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA203214
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-02

Drug Details

Active Ingredients

Ingredient	Strength
TOFACITINIB CITRATE	10 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" or generic name "Tofacitinib"

NDC	Brand Name	Generic Name
0069-0501	XELJANZ	tofacitinib
0069-0502	XELJANZ	tofacitinib
0069-1001	XELJANZ	tofacitinib
0069-1002	XELJANZ	tofacitinib
63539-012	XELJANZ	XELJANZ
63539-016	XELJANZ	XELJANZ
0069-1029	XELJANZ	XELJANZ