NDC 55700-590

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 Lake Erie Medical Dba Quality Care Products Llc. The primary component is Budesonide.

• Product ID: 55700-590_d7542bae-81ef-4e96-ad2b-203b7c94b060
• NDC: 55700-590
• 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: 2018-03-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206623
• Labeler Name: Lake Erie Medical DBA Quality Care Products LLC
• 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: 2019-12-31

Packaging

NDC 55700-590-90

90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (55700-590-90)

• Marketing Start Date: 2018-03-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55700-590-90 [55700059090]

BUDESONIDE (ENTERIC COATED) CAPSULE, DELAYED RELEASE PELLETS

• Marketing Category: ANDA
• Application Number: ANDA206623
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-03-09
• Marketing End Date: 2019-10-11

Drug Details

Active Ingredients

Ingredient	Strength
BUDESONIDE	3 mg/1

OpenFDA Data

• SPL SET ID: a48066b5-b71d-4702-8459-ce447542a276
• Manufacturer:
  • Lake Erie Medical DBA Quality Care Products LLC
• UNII:
  • Q3OKS62Q6X
• RxNorm Concept Unique ID - RxCUI:
  • 1244214

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