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

Additional Listing Data#

Finished product
Yes
Brand name base
Cefprozil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFPROZIL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4W0459ZA4V
Rxcui197452, 197453

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
228ef569-e7f1-4dcf-b820-c09522f86f2eProduct name120250129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-243-50Cefprozil50 in 1 BOTTLETABLET, FILM COATED506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-243-50EA - Each67877-2434c8afd8a-1198-4c63-90d8-d9aa9b80fa2e12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-243CEFPROZIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]5Current NDC, 1 package rows20250131_dc3e9cae-6f4f-4045-a11e-2fbf7f94c3c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197452cefprozil 250 MG Oral TabletPSNdc3e9cae-6f4f-4045-a11e-2fbf7f94c3c06
197453cefprozil 500 MG Oral TabletPSNdc3e9cae-6f4f-4045-a11e-2fbf7f94c3c06
197452cefprozil 250 MG Oral TabletSCDdc3e9cae-6f4f-4045-a11e-2fbf7f94c3c06
197453cefprozil 500 MG Oral TabletSCDdc3e9cae-6f4f-4045-a11e-2fbf7f94c3c06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67877-243-506787702435050 TABLET, FILM COATED in 1 BOTTLE (67877-243-50) 2025-01-20NoNoCurrent