NDC 58463-012

KEFLEX

Cephalexin

KEFLEX is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pragma Pharmaceuticals, L. The primary component is Cephalexin.

• Product ID: 58463-012_6e68ec39-9ddf-467d-9fbc-2c9dc39defd1
• NDC: 58463-012
• Product Type: Human Prescription Drug
• Proprietary Name: KEFLEX
• Generic Name: Cephalexin
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2016-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA050405
• Labeler Name: Pragma Pharmaceuticals, L
• Substance Name: CEPHALEXIN
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Cephalosporin A
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58463-012-01

100 CAPSULE in 1 BOTTLE (58463-012-01)

• Marketing Start Date: 2016-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58463-012-01 [58463001201]

KEFLEX CAPSULE

• Marketing Category: NDA
• Application Number: NDA050405
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-05-01

Drug Details

Pharmacological Class

• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]

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

NDC	Brand Name	Generic Name
58463-011	KEFLEX	KEFLEX
58463-012	KEFLEX	KEFLEX
58463-013	KEFLEX	KEFLEX
59630-112	Keflex	Keflex
59630-113	Keflex	Keflex
59630-115	Keflex	Keflex
61919-410	KEFLEX	KEFLEX
80425-0006	Keflex	Keflex
80425-0121	Keflex	Keflex
80425-0005	Keflex	Keflex
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