Cefprozil

Product NDC
67877-243
11-digit product format
678770243
Labeler code
67877
Product ID
67877-243_2e36bf51-2cc6-441a-ad40-6d752e3e4e9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefprozil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA090857
Marketing category
ANDA
Marketing start
2025-01-20
Substance
CEFPROZIL
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4W0459ZA4VCEFPROZIL121123-17-9CEFPROZIL

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67877-243-506787702435050 TABLET, FILM COATED in 1 BOTTLE (67877-243-50) 2025-01-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cefprozil - Ascend Laboratories, LLC | Alkem Laboratories LimitedAscend Laboratories, LLC | Alkem Laboratories Limited2025-05-30Human Prescription Drug Label6