STELARA
- Product NDC
- 57894-060
- 11-digit product format
- 578940060
- Labeler code
- 57894
- Product ID
- 57894-060_ff62ab2e-9413-4e22-95ad-74b582c14dc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ustekinumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Janssen Biotech, Inc.
- Application
- BLA125261
- Marketing category
- BLA
- Marketing start
- 2009-09-25
- Substance
- USTEKINUMAB
- Active strength
- 45 mg/.5mL
- Pharmacologic classes
- Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- STELARA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| USTEKINUMAB | 45 mg/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FU77B4U5Z0 |
| Rxcui | 853350, 853354, 853355, 853356, 1654077, 1654079, 1811255, 1811257 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57894-060-02 | STELARA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 47 |
| 57894-060-02 | STELARA | 0.5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 0.5 | | 47 |
| 57894-060-03 | STELARA | 0.5 mL in 1 SYRINGE | INJECTION, SOLUTION | 0.5 | | 47 |
| 57894-060-03 | STELARA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 47 |
| 57894-060-04 | STELARA | 0.5 mL in 1 SYRINGE | INJECTION, SOLUTION | 0.5 | | 47 |
| 57894-060-04 | STELARA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 47 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ustekinumab | ACTIVE INGREDIENT | FU77B4U5Z0 | STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 16 | |
| ustekinumab | ACTIVE MOIETY | FU77B4U5Z0 | STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 16 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 16 | |
| HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE | INACTIVE INGREDIENT | X573657P6P | STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 16 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 16 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 16 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 16 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57894-060 | STELARA (USTEKINUMAB) INJECTION, SOLUTION STELARA (USTEKINUMAB) SOLUTION [JANSSEN BIOTECH, INC.] | 43 | Current NDC, Legacy NDC, 6 package rows | 20250410_c77a9664-e3bb-4023-b400-127aa53bca2b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57894-060-02 | 57894006002 | 1 VIAL, SINGLE-USE in 1 CARTON (57894-060-02) / .5 mL in 1 VIAL, SINGLE-USE | | 2009-09-25 | 0000-00-00 | No | No | Current |
| 57894-060-03 | 57894006003 | 1 SYRINGE in 1 CARTON (57894-060-03) / .5 mL in 1 SYRINGE | 1 syringe | 2009-09-25 | 0000-00-00 | No | No | Current |
| 57894-060-04 | 57894006004 | 1 SYRINGE in 1 CARTON (57894-060-04) / .5 mL in 1 SYRINGE | 1 syringe | 2009-09-25 | 0000-00-00 | Yes | No | Current |