FDA.reportPublic FDA data

Cefadroxil

Product NDC
68180-181
11-digit product format
681800181
Labeler code
68180
Product ID
68180-181_3818bd15-cf3a-4b07-bef5-57169a33a170
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065396
Marketing category
ANDA
Marketing start
2008-04-23
Substance
CEFADROXIL
Active strength
250 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFADROXIL250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii280111G160
Rxcui105171, 309048

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
560bed03-0257-a1db-0638-2c46fc35054cProduct name220170824
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
34f1b9ee-0673-df8c-ddae-36eaf4c48382Product name120140508
3793572a-4958-68b2-f923-8cf695ec1cc1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-181-01Cefadroxil50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION509
68180-181-02Cefadroxil100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-181CEFADROXIL POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20250130_27009a05-4d2b-4618-be76-39f348240eda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309048cefadroxil 250 MG in 5 mL Oral SuspensionPSN27009a05-4d2b-4618-be76-39f348240eda9
105171cefadroxil 500 MG in 5 mL Oral SuspensionPSN27009a05-4d2b-4618-be76-39f348240eda9
105171cefadroxil 100 MG/ML Oral SuspensionSCD27009a05-4d2b-4618-be76-39f348240eda9
309048cefadroxil 50 MG/ML Oral SuspensionSCD27009a05-4d2b-4618-be76-39f348240eda9
105171cefadroxil (as cefadroxil monohydrate) 100 MG/ML Oral SuspensionSY27009a05-4d2b-4618-be76-39f348240eda9
309048cefadroxil (as cefadroxil monohydrate) 50 MG/ML Oral SuspensionSY27009a05-4d2b-4618-be76-39f348240eda9
309048cefadroxil 250 MG per 5 ML Powder for Oral SuspensionSY27009a05-4d2b-4618-be76-39f348240eda9
105171cefadroxil 500 MG per 5 ML Powder for Oral SuspensionSY27009a05-4d2b-4618-be76-39f348240eda9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-181-016818001810150 mL in 1 BOTTLE (68180-181-01) 50 ml2008-04-230000-00-00NoNoCurrent
68180-181-0268180018102100 mL in 1 BOTTLE (68180-181-02) 100 ml2008-04-230000-00-00NoNoCurrent