NDC 50090-0714-1
API & Excipient Details

Amoxicillin Trihydrate marketed by A-S Medication Solutions under NDC Code 50090-0714-1

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	875 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50090-0714-0	20 in 1 BOTTLE Type 0: Not a Combination Product	28/11/2014
2	NDC:50090-0714-1	14 in 1 BOTTLE Type 0: Not a Combination Product	14/12/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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