Cephalexin

Product NDC
55289-058
11-digit product format
552890058
Labeler code
55289
Product ID
55289-058_4304de4b-4197-e324-e063-6394a90ad3d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA062702
Marketing category
ANDA
Marketing start
1990-09-30
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
OBN7UDS42YCEPHALEXIN23325-78-2CEPHALEXIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55289-058-105528900581010 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-10) 10 capsule2011-06-06NoNoHistorical
55289-058-145528900581414 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-14) 14 capsule2011-06-06NoNoHistorical
55289-058-205528900582020 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-20) 20 capsule2011-06-06NoNoHistorical
55289-058-285528900582828 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-28) 28 capsule2011-06-06NoNoHistorical
55289-058-305528900583030 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-30) 30 capsule2011-06-06NoNoHistorical
55289-058-405528900584040 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-40) 40 capsule2011-06-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CephalexinPD-Rx Pharmaceuticals, Inc.2025-11-07HUMAN PRESCRIPTION DRUG LABEL25
CephalexinPD-Rx Pharmaceuticals, Inc.2024-10-09HUMAN PRESCRIPTION DRUG LABEL23