NDC 0093-7445

Budesonide (Enteric Coated)

Budesonide

Budesonide (Enteric Coated) is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Budesonide.

• Product ID: 0093-7445_533ad905-d102-4eaf-a2b2-65ca3458d679
• NDC: 0093-7445
• Product Type: Human Prescription Drug
• Proprietary Name: Budesonide (Enteric Coated)
• Generic Name: Budesonide
• Dosage Form: Capsule, Delayed Release Pellets
• Route of Administration: ORAL
• Marketing Start Date: 2016-06-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090379
• Labeler Name: Teva Pharmaceuticals USA, Inc.
• Substance Name: BUDESONIDE
• Active Ingredient Strength: 3 mg/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0093-7445-01

100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0093-7445-01)

• Marketing Start Date: 2016-06-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0093-7445-01 [00093744501]

Budesonide (Enteric Coated) CAPSULE, DELAYED RELEASE PELLETS

• Marketing Category: ANDA
• Application Number: ANDA090379
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-06-23
• Marketing End Date: 2021-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BUDESONIDE	3 mg/1

OpenFDA Data

• SPL SET ID: bac8e404-b443-4264-ba47-f793f4f676bc
• Manufacturer:
  • Teva Pharmaceuticals USA, Inc.
• UNII:
  • Q3OKS62Q6X
• RxNorm Concept Unique ID - RxCUI:
  • 1244214
• UPC Code:
  • 0300937445012

Pharmacological Class

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

NDC Crossover Matching brand name "Budesonide (Enteric Coated)" or generic name "Budesonide"

NDC	Brand Name	Generic Name
47781-146	Budesonide (enteric coated)	Budesonide (enteric coated)
51862-582	BUDESONIDE (ENTERIC COATED)	BUDESONIDE (ENTERIC COATED)
55700-590	BUDESONIDE (ENTERIC COATED)	BUDESONIDE (ENTERIC COATED)
51862-580	BUDESONIDE (ENTERIC COATED)	BUDESONIDE (ENTERIC COATED)
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