Search by Drug Name or NDC
NDC 00069-1002-01 XELJANZ 10 mg/1 Details
XELJANZ 10 mg/1
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.
MedlinePlus Drug Summary
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.
Related Packages: 00069-1002-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tofacitinib
Product Information
| NDC | 00069-1002 |
|---|---|
| Product ID | 0069-1002_b66d67c5-58ad-437e-a098-1e4a18d1104d |
| Associated GPIs | 66603065100330 |
| GCN Sequence Number | 078538 |
| GCN Sequence Number Description | tofacitinib citrate TABLET 10 MG ORAL |
| HIC3 | Z2Z |
| HIC3 Description | JANUS KINASE (JAK) INHIBITORS |
| GCN | 44882 |
| HICL Sequence Number | 039768 |
| HICL Sequence Number Description | TOFACITINIB CITRATE |
| Brand/Generic | Brand |
| Proprietary Name | XELJANZ |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | tofacitinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | TOFACITINIB CITRATE |
| Labeler Name | Pfizer Laboratories Div Pfizer Inc |
| Pharmaceutical Class | Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA203214 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00069-1002-01 (00069100201)
| NDC Package Code | 0069-1002-01 |
|---|---|
| Billing NDC | 00069100201 |
| Package | 60 TABLET, FILM COATED in 1 BOTTLE (0069-1002-01) |
| Marketing Start Date | 2018-07-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |