Cefadroxil

Product NDC
16714-390
11-digit product format
167140390
Labeler code
16714
Product ID
16714-390_323b9a4d-c8fc-4fdb-bba4-834468a0a770
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA065349
Marketing category
ANDA
Marketing start
2013-04-25
Substance
CEFADROXIL
Active strength
500 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
CEFADROXIL500 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii280111G160
Rxcui105171, 309048

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
560bed03-0257-a1db-0638-2c46fc35054cProduct name220170824
34f1b9ee-0673-df8c-ddae-36eaf4c48382Product name120140508
3793572a-4958-68b2-f923-8cf695ec1cc1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-390-01Cefadroxil75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION757
16714-390-02Cefadroxil100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-390-01ML - Milliliter16714-3905e2066bc-2967-4271-8827-1de5cf5af62f12013-09-04
16714-390-02ML - Milliliter16714-3905d12ae10-dc46-40f6-9d5c-739c6536ac6212013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]2
CEFADROXIL ANHYDROUSACTIVE MOIETYQ525PA8JJBCEFADROXIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEFADROXIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCEFADROXIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFADROXIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554CEFADROXIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]2
SULFUR DIOXIDEINACTIVE INGREDIENT0UZA3422Q4CEFADROXIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFADROXIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-390CEFADROXIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]7Current NDC, Legacy NDC, 2 package rows20240213_30bb3686-87b4-4676-9ff5-e20deb8bff9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309048cefadroxil 250 MG in 5 mL Oral SuspensionPSN30bb3686-87b4-4676-9ff5-e20deb8bff9d7
105171cefadroxil 500 MG in 5 mL Oral SuspensionPSN30bb3686-87b4-4676-9ff5-e20deb8bff9d7
105171cefadroxil 100 MG/ML Oral SuspensionSCD30bb3686-87b4-4676-9ff5-e20deb8bff9d7
309048cefadroxil 50 MG/ML Oral SuspensionSCD30bb3686-87b4-4676-9ff5-e20deb8bff9d7
105171cefadroxil (as cefadroxil monohydrate) 100 MG/ML Oral SuspensionSY30bb3686-87b4-4676-9ff5-e20deb8bff9d7
309048cefadroxil (as cefadroxil monohydrate) 50 MG/ML Oral SuspensionSY30bb3686-87b4-4676-9ff5-e20deb8bff9d7
309048cefadroxil 250 MG per 5 ML Powder for Oral SuspensionSY30bb3686-87b4-4676-9ff5-e20deb8bff9d7
105171cefadroxil 500 MG per 5 ML Powder for Oral SuspensionSY30bb3686-87b4-4676-9ff5-e20deb8bff9d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-390-011671403900175 mL in 1 BOTTLE (16714-390-01) 75 ml2013-04-250000-00-00NoNoCurrent
16714-390-0216714039002100 mL in 1 BOTTLE (16714-390-02) 100 ml2013-04-250000-00-00NoNoCurrent