XELJANZ
- Product NDC
- 0069-0502
- 11-digit product format
- 000690502
- Labeler code
- 0069
- Product ID
- 0069-0502_39aa36a4-7b51-43af-9bf0-d812b3f9bd1d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tofacitinib
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA208246
- Marketing category
- NDA
- Marketing start
- 2020-01-21
- Substance
- TOFACITINIB CITRATE
- Active strength
- 22 mg/1
- Pharmacologic classes
- Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- XELJANZ
- Brand name suffix
- XR
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOFACITINIB CITRATE | 22 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O1FF4DIV0D |
| Rxcui | 1357541, 1357547, 1741046, 1741049, 2048566, 2048568, 2273113, 2273115, 2478433, 2478437 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0069-0502-30 | XELJANZXR | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 53 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOFACITINIB CITRATE | ACTIVE INGREDIENT | O1FF4DIV0D | XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 12 | |
| TOFACITINIB | ACTIVE MOIETY | 87LA6FU830 | XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 12 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 12 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 12 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 12 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 12 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 12 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 12 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0069-0502 | XELJANZ (TOFACITINIB) TABLET, FILM COATED XELJANZ XR (TOFACITINIB) TABLET, FILM COATED, EXTENDED RELEASE XELJANZ (TOFACITINIB) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 49 | Current NDC, Legacy NDC, 1 package rows | 20241222_cf74ba2f-afc5-4baa-8594-979c889a5831.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0069-0502-30 | 00069050230 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0502-30) | 2020-01-21 | 0000-00-00 | No | No | Current |