Amoxicillin (Page 5 of 5)

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

Rx only
NDC 16714-298-01
Amoxicillin
Capsules, USP
250 mg
100 Capsules
Northstar RxTM

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 250 mg (100 Capsules Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (100 Capsule Bottle)

Rx only
NDC 16714-299-03
Amoxicillin
Capsules, USP
500 mg
100 Capsules
Northstar RxTM

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg (100 Capsule Bottle)
(click image for full-size original)

AMOXICILLIN amoxicillin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-298
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 250 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
MAGNESIUM STEARATE
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color BLUE, PINK Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code A44
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-298-01 100 CAPSULE in 1 BOTTLE None
2 NDC:16714-298-02 500 CAPSULE in 1 BOTTLE None
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 Item Code (Source) NDC:16714-299
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
MAGNESIUM STEARATE
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color BLUE, PINK Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code A45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-299-01 30 CAPSULE in 1 BOTTLE None
2 NDC:16714-299-02 50 CAPSULE in 1 BOTTLE None
3 NDC:16714-299-03 100 CAPSULE in 1 BOTTLE None
4 NDC:16714-299-04 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065271 11/09/2005
Labeler — NorthStar Rx LLC (830546433)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917683 ANALYSIS (16714-298), ANALYSIS (16714-299), MANUFACTURE (16714-298), MANUFACTURE (16714-299)

Revised: 09/2019 NorthStar Rx LLC

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