Cefdinir

Product NDC
76420-327
11-digit product format
764200327
Labeler code
76420
Product ID
76420-327_331b63bf-fd36-155d-e063-6294a90aec23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA065259
Marketing category
ANDA
Marketing start
2006-05-31
Substance
CEFDINIR
Active strength
125 mg/5mL
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
CI0FAO63WCCEFDINIR91832-40-5CEFDINIR

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-327-0176420032701100 mL in 1 BOTTLE (76420-327-01) 100 ml2025-04-19NoNoHistorical
76420-327-607642003276060 mL in 1 BOTTLE (76420-327-60) 60 ml2025-04-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cefdinir for Oral Suspension USPAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2025-04-19HUMAN PRESCRIPTION DRUG LABEL1