NDC 59630-820

Cedax

Ceftibuten Dihydrate

Cedax is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sciele Pharma, Inc.. The primary component is Ceftibuten Dihydrate.

• Product ID: 59630-820_d1672f05-b1ee-40f9-9b4c-7ba2fad264fc
• NDC: 59630-820
• Product Type: Human Prescription Drug
• Proprietary Name: Cedax
• Generic Name: Ceftibuten Dihydrate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1995-12-20
• Marketing Category: NDA / NDA
• Application Number: NDA050685
• Labeler Name: Sciele Pharma, Inc.
• Substance Name: CEFTIBUTEN DIHYDRATE
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 59630-820-20

20 CAPSULE in 1 BOTTLE (59630-820-20)

• Marketing Start Date: 1995-12-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59630-820-20 [59630082020]

Cedax CAPSULE

• Marketing Category: NDA
• Application Number: NDA050685
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1995-12-20
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
CEFTIBUTEN DIHYDRATE	400 mg/1

OpenFDA Data

• SPL SET ID: 2dd58c88-142f-41ad-bc31-0a4fff074970
• Manufacturer:
  • Sciele Pharma, Inc.
• UNII:
  • 62F4443RWP
• RxNorm Concept Unique ID - RxCUI:
  • 108395
  • 581580
  • 309086
  • 309087

Pharmacological Class

• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]

NDC Crossover Matching brand name "Cedax" or generic name "Ceftibuten Dihydrate"

NDC	Brand Name	Generic Name
59630-820	Cedax	Ceftibuten dihydrate
59630-821	Cedax	Ceftibuten dihydrate