NDC Code(s) : 57237-030-01, 57237-030-05, 57237-031-01, 57237-031-05
Packager : Rising Pharma Holdings, Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amoxicillin Amoxicillin CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:57237-030
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color BLUE, PINK Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code A44
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57237-030-01100 in 1 BOTTLE Type 0: Not a Combination Product11/09/2005
2NDC:57237-030-05500 in 1 BOTTLE Type 0: Not a Combination Product11/09/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065271 11/09/2005
Amoxicillin Amoxicillin CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:57237-031
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color BLUE, PINK Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code A45
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57237-031-01100 in 1 BOTTLE Type 0: Not a Combination Product11/09/2005
2NDC:57237-031-05500 in 1 BOTTLE Type 0: Not a Combination Product11/09/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065271 11/09/2005

LABELER - Rising Pharma Holdings, Inc.(116880195)

REGISTRANT - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917683 ANALYSIS(57237-030, 57237-031), MANUFACTURE(57237-030, 57237-031)

PRINCIPAL DISPLAY PANEL

Rising®             NDC 57237-030-01
Amoxicillin Capsules, USP
250 mg

AMOXICILLIN, 250 mg as the trihydrate

100 Capsules         Rx only



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg (100 Capsules Bottle)

PRINCIPAL DISPLAY PANEL


Rising®             NDC 57237-031-01
Amoxicillin Capsules, USP
500 mg

AMOXICILLIN, 500 mg as the trihydrate

100 Capsules         Rx only
 
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (100 Capsule Bottle)