NDC 57894-054

Stelara

Ustekinumab

Stelara is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Ustekinumab.

• Product ID: 57894-054_17da6982-46cb-4cc7-a05b-12c3370734d1
• NDC: 57894-054
• Product Type: Human Prescription Drug
• Proprietary Name: Stelara
• Generic Name: Ustekinumab
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-09-23
• Marketing Category: BLA / BLA
• Application Number: BLA761044
• Labeler Name: Janssen Biotech, Inc.
• Substance Name: USTEKINUMAB
• Active Ingredient Strength: 130 mg/26mL
• Pharm Classes: Interleukin-12 Antagonists [MoA],Interleukin-23 Antagonist [EPC],Interleukin-23 Antagonists [MoA],Interleukin-12 Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 57894-054-16

1 VIAL, SINGLE-USE in 1 BOX (57894-054-16) > 26 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2017-05-01
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 57894-054-16 [57894005416]

Stelara SOLUTION

• Marketing Category: BLA
• Application Number: BLA761044
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-01

NDC 57894-054-27 [57894005427]

Stelara SOLUTION

• Marketing Category: BLA
• Application Number: BLA761044
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-09-23

Drug Details

Active Ingredients

Ingredient	Strength
USTEKINUMAB	130 mg/26mL

OpenFDA Data

• SPL SET ID: c77a9664-e3bb-4023-b400-127aa53bca2b
• Manufacturer:
  • Janssen Biotech, Inc.
• UNII:
  • FU77B4U5Z0
• RxNorm Concept Unique ID - RxCUI:
  • 1811255
  • 1811257
  • 853356
  • 853354
  • 853355
  • 853350
  • 1654083
  • 1654082
  • 1654077
  • 1654079

Pharmacological Class

• Interleukin-12 Antagonists [MoA]
• Interleukin-23 Antagonist [EPC]
• Interleukin-23 Antagonists [MoA]
• Interleukin-12 Antagonist [EPC]

NDC Crossover Matching brand name "Stelara" or generic name "Ustekinumab"

NDC	Brand Name	Generic Name
57894-054	Stelara	ustekinumab
57894-060	STELARA	ustekinumab
57894-061	STELARA	ustekinumab