FDA.reportPublic FDA data

Cefprozil

Product NDC
65862-068
11-digit product format
658620068
Labeler code
65862
Product ID
65862-068_6397ff45-3c37-40c3-a924-d036bb896b3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefprozil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA065340
Marketing category
ANDA
Marketing start
2007-05-24
Substance
CEFPROZIL
Active strength
250 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
CEFPROZIL250 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
65862-068-01Cefprozil100 in 1 BOTTLETABLET, FILM COATED10011
65862-068-05Cefprozil500 in 1 BOTTLETABLET, FILM COATED50011
65862-068-30Cefprozil30 in 1 BOTTLETABLET, FILM COATED3011
65862-068-50Cefprozil50 in 1 BOTTLETABLET, FILM COATED5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-068-01EA - Each65862-068350dd902-b09d-4a29-a0ed-2872df52b2b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFPROZILACTIVE INGREDIENT4W0459ZA4VCEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
CEFPROZIL ANHYDROUSACTIVE MOIETY1M698F4H4ECEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XCEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
SHELLACINACTIVE INGREDIENT46N107B71OCEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-068CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 4 package rows20240507_b9111a81-07c4-4458-b994-a4ad504986d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197452cefprozil 250 MG Oral TabletPSNb9111a81-07c4-4458-b994-a4ad504986d811
197453cefprozil 500 MG Oral TabletPSNb9111a81-07c4-4458-b994-a4ad504986d811
197452cefprozil 250 MG Oral TabletSCDb9111a81-07c4-4458-b994-a4ad504986d811
197453cefprozil 500 MG Oral TabletSCDb9111a81-07c4-4458-b994-a4ad504986d811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-068-0165862006801100 TABLET, FILM COATED in 1 BOTTLE (65862-068-01) 2007-05-240000-00-00NoNoCurrent
65862-068-0565862006805500 TABLET, FILM COATED in 1 BOTTLE (65862-068-05) 2007-05-240000-00-00NoNoCurrent
65862-068-306586200683030 TABLET, FILM COATED in 1 BOTTLE (65862-068-30) 2007-05-240000-00-00NoNoCurrent
65862-068-506586200685050 TABLET, FILM COATED in 1 BOTTLE (65862-068-50) 2007-05-240000-00-00NoNoCurrent