NDC Code(s) : 50090-4320-0, 50090-4320-1, 50090-4320-2, 50090-4320-5, 50090-4320-7
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AmoxicillinAmoxicillin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4320(NDC:0093-3109)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS500 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
METHYLPARABEN(UNII: A2I8C7HI9T)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color BROWN (buff) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code TEVA;3109
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-4320-030 in 1 BOTTLE Type 0: Not a Combination Product30/05/2019
2NDC:50090-4320-140 in 1 BOTTLE Type 0: Not a Combination Product30/05/2019
3NDC:50090-4320-221 in 1 BOTTLE Type 0: Not a Combination Product30/05/2019
4NDC:50090-4320-515 in 1 BOTTLE Type 0: Not a Combination Product30/05/2019
5NDC:50090-4320-710 in 1 BOTTLE Type 0: Not a Combination Product30/05/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061926 09/30/1990

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-4320), REPACK(50090-4320)

PRINCIPAL DISPLAY PANEL

Label Image