NDC 0069-1002 Xeljanz
Tofacitinib Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 0069 - Pfizer Laboratories Div Pfizer Inc
- 0069-1002 - Xeljanz
Product Characteristics
PINK (C48328 - PINK)
BLUE (C48333)
OVAL (C48345)
11 MM
10 MM
JKI11
PFIZER;JKI10
Product Packages
NDC Code 0069-1002-01
Package Description: 60 TABLET, FILM COATED in 1 BOTTLE
Product Details
What is NDC 0069-1002?
What are the uses for Xeljanz?
What are Xeljanz Active Ingredients?
Which are Xeljanz UNII Codes?
The UNII codes for the active ingredients in this product are:
- TOFACITINIB CITRATE (UNII: O1FF4DIV0D)
- TOFACITINIB (UNII: 87LA6FU830) (Active Moiety)
Which are Xeljanz Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- TRIACETIN (UNII: XHX3C3X673)
- POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
- HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
- SORBITOL (UNII: 506T60A25R)
- HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
- COPOVIDONE K25-31 (UNII: D9C330MD8B)
- CELLULOSE ACETATE (UNII: 3J2P07GVB6)
- HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- SHELLAC (UNII: 46N107B71O)
- AMMONIA (UNII: 5138Q19F1X)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
What is the NDC to RxNorm Crosswalk for Xeljanz?
- RxCUI: 1357541 - tofacitinib 5 MG Oral Tablet
- RxCUI: 1357541 - tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet
- RxCUI: 1357547 - Xeljanz 5 MG Oral Tablet
- RxCUI: 1357547 - tofacitinib 5 MG Oral Tablet [Xeljanz]
- RxCUI: 1357547 - Xeljanz 5 MG (as tofacitinib citrate 8 MG) Oral Tablet
Which are the Pharmacologic Classes for Xeljanz?
* Please review the disclaimer below.
Patient Education
Tofacitinib
Tofacitinib is used alone or with other medications to treat rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function) in adults who are unable to take or did not respond to one or more tumor necrosis factor (TNF) inhibitor medication(s). It is also used to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults who are unable to take or did not respond to or tolerate one or more TNF inhibitor medication(s). Tofacitinib is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s). It is also used to treat polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function) in children 2 years and older who are unable to take or who did not respond to one or more TNF inhibitor medication(s). Tofacitinib is in a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system.
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".