NDC Code(s) : 50090-0714-0, 50090-0714-1
Packager : A-S Medication Solutions

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amoxicillin Amoxicillin TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:50090-0714(NDC:65862-015)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS875 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
D&C RED NO. 30(UNII: 2S42T2808B)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL (CAPSULE-SHAPED) Size 21 mm
Flavor Imprint Code A;6;7
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-0714-020 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
2NDC:50090-0714-114 in 1 BOTTLE Type 0: Not a Combination Product14/12/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065256 11/09/2005

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-0714), REPACK(50090-0714)

PRINCIPAL DISPLAY PANEL

Label Image