63539-501 : Xeljanz 11 mg Oral Tablet, Extended Release


NDC: 63539-501
Labeler: U.S. Pharmaceuticals
Product Type: Human Prescription Drug
Drug Name:  Xeljanz XR
Dosage Form: Oral Tablet, Extended Release
Application #: NDA208246
Rev. Date: 


Appearance:


Markings: JKI11
Shapes:  Oval
Colors:  Pink
Size (mm): 8
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 63539-501-14: 14 TABLET, EXTENDED RELEASE IN 1 BOTTLE (63539‑501‑14)
  • 63539-501-30: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (63539‑501‑30)

Active Ingredients:

  • Tofacitinib Citrate

Dosage Strength:

  • 11 mg

Inactive Ingredients:

  • Sorbitol
  • Hydroxyethyl Cellulose (140 Mpa.s At 5%)
  • Copovidone
  • Magnesium Stearate
  • Cellulose Acetate
  • Hydroxypropyl Cellulose (1200000 Mw)
  • Titanium Dioxide
  • Hypromellose 2910 (6 Mpa.s)
  • Triacetin
  • Ferric Oxide Red
  • Shellac
  • Ammonia
  • Propylene Glycol
  • Ferrosoferric Oxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 63539-502 Xeljanz 22 mg Oral Tablet, Extended Release by U.S. Pharmaceuticals
  • 0069-0501 Xeljanz 11 mg Oral Tablet, Film Coated, Extended Release by Pfizer Laboratories Div Pfizer Inc
  • 0069-0502 Xeljanz 22 mg Oral Tablet, Film Coated, Extended Release by Pfizer Laboratories Div Pfizer Inc

NDC QR Code

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NDC 63539-501 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.