NDC 65483-702

ENTOCORT EC

Budesonide

ENTOCORT EC is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Prometheus Laboratories Inc. The primary component is Budesonide.

• Product ID: 65483-702_c99a57a5-655a-4ded-9397-eb7881a3e670
• NDC: 65483-702
• Product Type: Human Prescription Drug
• Proprietary Name: ENTOCORT EC
• Generic Name: Budesonide
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2001-10-29
• Marketing Category: NDA / NDA
• Application Number: NDA021324
• Labeler Name: Prometheus Laboratories Inc
• Substance Name: BUDESONIDE
• Active Ingredient Strength: 3 mg/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 65483-702-10

100 CAPSULE in 1 BOTTLE (65483-702-10)

• Marketing Start Date: 2001-10-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65483-702-10 [65483070210]

ENTOCORT EC CAPSULE

• Marketing Category: NDA
• Application Number: NDA021324
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-10-29
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
BUDESONIDE	3 mg/1

OpenFDA Data

• SPL SET ID: fe6530ef-1b23-451f-1290-0e3ef02ec1b5
• Manufacturer:
  • Prometheus Laboratories Inc
• UNII:
  • Q3OKS62Q6X
• RxNorm Concept Unique ID - RxCUI:
  • 1244215
  • 1244214

Pharmacological Class

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

Medicade Reported Pricing

65483070210 ENTOCORT EC 3 MG CAPSULE

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "ENTOCORT EC" or generic name "Budesonide"

NDC	Brand Name	Generic Name
0574-9850	Entocort EC	Entocort EC
65483-702	ENTOCORT EC	ENTOCORT EC
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