NDC Code(s) : 57237-028-20, 57237-028-01, 57237-029-20, 57237-029-01
Packager : Rising Pharma Holdings, Inc.

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:57237-028
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(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 no score
Shape OVAL (CAPSULE-SHAPED) Size 18 mm
Flavor Imprint Code A;66
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57237-028-2020 in 1 BOTTLE Type 0: Not a Combination Product11/09/2005
2NDC:57237-028-01100 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 ANDA065256 11/09/2005
Amoxicillin Amoxicillin TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:57237-029
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 (120 .MU.M)(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:57237-029-2020 in 1 BOTTLE Type 0: Not a Combination Product11/09/2005
2NDC:57237-029-01100 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 ANDA065256 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(57237-028, 57237-029), MANUFACTURE(57237-028, 57237-029)

PRINCIPAL DISPLAY PANEL


Rising®      NDC 57237-028-01
Amoxicillin
Tablets, USP
500 mg

AMOXICILLIN, 500 mg as the trihydrate

100 Tablets    Rx only
Figure 1

PRINCIPAL DISPLAY PANEL

Rising®      NDC 57237-029-01
Amoxicillin
Tablets, USP
875 mg

AMOXICILLIN, 875 mg as the trihydrate
100 Tablets         Rx only
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 875 mg (100 Tablets Bottle)