NDC Code(s) : 55289-019-06, 55289-019-15, 55289-019-21, 55289-019-24, 55289-019-30, 55289-019-40, 55289-019-60
Packager : PD-Rx Pharmaceuticals, Inc.

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:55289-019(NDC:0093-3107)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS250 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C BLUE NO. 2 ALUMINUM LAKE(UNII: 4AQJ3LG584)
Product Characteristics
Color brown (caramel), brown (buff) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code TEVA;3107
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55289-019-066 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/11/2011
2NDC:55289-019-1515 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/11/2011
3NDC:55289-019-2121 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/11/2011
4NDC:55289-019-2424 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/11/2011
5NDC:55289-019-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/11/2011
6NDC:55289-019-4040 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/11/2011
7NDC:55289-019-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/11/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061926 09/30/1990

LABELER - PD-Rx Pharmaceuticals, Inc.(156893695)

REGISTRANT - PD-Rx Pharmaceuticals, Inc.(156893695)

Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(55289-019)

PRINCIPAL DISPLAY PANEL

Amoxicillin Capsules, USP
250 mg
Rx only

55289019 Label