Amoxicillin and Clavulanate Potassium

Product NDC
0093-2270
11-digit product format
000932270
Labeler code
0093
Product ID
0093-2270_f7eeea58-2ba1-4ec1-a3b1-dbad63d1822c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065205
Marketing category
ANDA
Marketing start
2005-03-22
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
200 mg/1; mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-2270-34EA - Each0093-22704e695c8d-556e-42a0-9b12-267a0f03122a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGAAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
TRIACETININACTIVE INGREDIENTXHX3C3X673AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-2270AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA, INC.]29Legacy NDC20240824_963e7bea-ff5d-420a-9cb2-e4aefb534b33.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-2270-340009322703420 TABLET, CHEWABLE in 1 BOTTLE (0093-2270-34) 2005-03-220000-00-00NoNoCurrent