NDC 65649-651

Uceris

Budesonide

Uceris is a Rectal Aerosol, Foam in the Human Prescription Drug category. It is labeled and distributed by Salix Pharmaceuticals, Inc.. The primary component is Budesonide.

• Product ID: 65649-651_636256c1-e782-4ffa-a4fb-082bf42c8697
• NDC: 65649-651
• Product Type: Human Prescription Drug
• Proprietary Name: Uceris
• Generic Name: Budesonide
• Dosage Form: Aerosol, Foam
• Route of Administration: RECTAL
• Marketing Start Date: 2014-12-01
• Marketing Category: NDA / NDA
• Application Number: NDA205613
• Labeler Name: Salix Pharmaceuticals, Inc.
• Substance Name: BUDESONIDE
• Active Ingredient Strength: 28 mg/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 65649-651-03

2 CANISTER in 1 CARTON (65649-651-03) > 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02)

• Marketing Start Date: 2014-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65649-651-03 [65649065103]

Uceris AEROSOL, FOAM

• Marketing Category: NDA
• Application Number: NDA205613
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-12-01

NDC 65649-651-02 [65649065102]

Uceris AEROSOL, FOAM

• Marketing Category: NDA
• Application Number: NDA205613
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-12-01

Drug Details

Active Ingredients

Ingredient	Strength
BUDESONIDE	28 mg/1

OpenFDA Data

• SPL SET ID: 230e4596-2a9b-4d55-b0a0-0cabbcff5289
• Manufacturer:
  • Salix Pharmaceuticals, Inc.
• UNII:
  • Q3OKS62Q6X
• RxNorm Concept Unique ID - RxCUI:
  • 1596778
  • 1596779

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

Medicade Reported Pricing

65649065103 UCERIS 2 MG RECTAL FOAM

Pricing Unit: GM | Drug Type:

NDC Crossover Matching brand name "Uceris" or generic name "Budesonide"

NDC	Brand Name	Generic Name
68012-309	Uceris	Uceris
65649-651	Uceris	Uceris
0093-6815	Budesonide	Budesonide
0093-6816	Budesonide	Budesonide
0093-6817	Budesonide	Budesonide
0093-7445	Budesonide	Budesonide
0115-1687	Budesonide Inhalation	Budesonide
0115-1689	Budesonide Inhalation	Budesonide
0186-0916	PULMICORT	Budesonide
0186-0917	PULMICORT	Budesonide
0186-1988	PULMICORT RESPULES	Budesonide
0186-1989	PULMICORT RESPULES	Budesonide
0186-1990	PULMICORT RESPULES	Budesonide