FDA.reportPublic FDA data

CEFPROZIL

Product NDC
68180-404
11-digit product format
681800404
Labeler code
68180
Product ID
68180-404_b5bc3f77-ca01-4c3f-b8b6-591a3d8f73f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFPROZIL
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065276
Marketing category
ANDA
Marketing start
2005-12-01
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
68180-404-01CEFPROZIL50 in 1 BOTTLETABLET5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-404-01EA - Each68180-4048678e760-3b17-4ec6-82a1-23cdc9ad2ea512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFPROZILACTIVE INGREDIENT4W0459ZA4VCEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.]3
CEFPROZILACTIVE INGREDIENT4W0459ZA4VCEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.]3
CEFPROZIL ANHYDROUSACTIVE MOIETY1M698F4H4ECEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.]3
CEFPROZIL ANHYDROUSACTIVE MOIETY1M698F4H4ECEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.]3
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8CEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.]3
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.]3
CEFPROZILACTIVE INGREDIENT4W0459ZA4VCEFPROZIL TABLET [REDPHARM DRUG INC.]2
CEFPROZIL ANHYDROUSACTIVE MOIETY1M698F4H4ECEFPROZIL TABLET [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFPROZIL TABLET [REDPHARM DRUG INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFPROZIL TABLET [REDPHARM DRUG INC.]2
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8CEFPROZIL TABLET [REDPHARM DRUG INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEFPROZIL TABLET [REDPHARM DRUG INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFPROZIL TABLET [REDPHARM DRUG INC.]2
CEFPROZILACTIVE INGREDIENT4W0459ZA4VCEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.]1
CEFPROZIL ANHYDROUSACTIVE MOIETY1M698F4H4ECEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.]1
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8CEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-404CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 1 package rows20250130_14527f4a-ce99-449d-a5a5-9edd7fb28dee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197452cefprozil 250 MG Oral TabletPSN14527f4a-ce99-449d-a5a5-9edd7fb28dee10
197453cefprozil 500 MG Oral TabletPSN14527f4a-ce99-449d-a5a5-9edd7fb28dee10
197452cefprozil 250 MG Oral TabletSCD14527f4a-ce99-449d-a5a5-9edd7fb28dee10
197453cefprozil 500 MG Oral TabletSCD14527f4a-ce99-449d-a5a5-9edd7fb28dee10
197453cefprozil 500 MG Oral TabletPSN17a1975e-ce3b-4057-ae5b-8d191319caa73
197453cefprozil 500 MG Oral TabletSCD17a1975e-ce3b-4057-ae5b-8d191319caa73
197453cefprozil 500 MG Oral TabletPSN0f96e4fe-8daf-492b-8fd8-90ff252430772
197453cefprozil 500 MG Oral TabletSCD0f96e4fe-8daf-492b-8fd8-90ff252430772
197453cefprozil 500 MG Oral TabletPSN75d57e35-ffeb-4d88-8dba-5458e284fd821
197453cefprozil 500 MG Oral TabletPSNf6c29d0f-c00e-44c9-a7e6-70ad143bb5641
197453cefprozil 500 MG Oral TabletSCD75d57e35-ffeb-4d88-8dba-5458e284fd821
197453cefprozil 500 MG Oral TabletSCDf6c29d0f-c00e-44c9-a7e6-70ad143bb5641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-404-016818004040150 TABLET in 1 BOTTLE (68180-404-01) 50 tablet2005-12-010000-00-00NoNoCurrent
68180-404-0268180040402100 TABLET in 1 BOTTLE (68180-404-02) 100 tablet2005-12-010000-00-00NoNoCurrent