NDC 0316-0333

Daxbia

Cephalexin

Daxbia is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Crown Laboratories, Inc.. The primary component is Cephalexin.

• Product ID: 0316-0333_97337af8-87fd-495c-ae18-f4ae1b658aef
• NDC: 0316-0333
• Product Type: Human Prescription Drug
• Proprietary Name: Daxbia
• Generic Name: Cephalexin
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2016-12-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090836
• Labeler Name: Crown Laboratories, Inc.
• Substance Name: CEPHALEXIN
• Active Ingredient Strength: 333 mg/1
• Pharm Classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0316-0333-10

100 CAPSULE in 1 BOTTLE (0316-0333-10)

• Marketing Start Date: 2016-12-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0316-0333-10 [00316033310]

Daxbia CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA090836
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-12-26
• Marketing End Date: 2019-07-04

Drug Details

Active Ingredients

Ingredient	Strength
CEPHALEXIN	333 mg/1

OpenFDA Data

• SPL SET ID: 8d5fd428-ea57-480d-a88e-020c26d01c1e
• Manufacturer:
  • Crown Laboratories, Inc.
• UNII:
  • OBN7UDS42Y
• RxNorm Concept Unique ID - RxCUI:
  • 645617
  • 1867697
• UPC Code:
  • 0303160333101

Pharmacological Class

• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]

NDC Crossover Matching brand name "Daxbia" or generic name "Cephalexin"

NDC	Brand Name	Generic Name
0316-0333	Daxbia	Daxbia
0093-2238	Cephalexin	Cephalexin
0093-2240	Cephalexin	Cephalexin
0093-3145	Cephalexin	Cephalexin
0093-3147	Cephalexin	Cephalexin
0093-4175	Cephalexin	Cephalexin
0093-4177	Cephalexin	Cephalexin
0143-9769	Cephalexin	Cephalexin
0143-9770	Cephalexin	Cephalexin
0143-9897	Cephalexin	Cephalexin
0143-9898	Cephalexin	Cephalexin