Indomethacin (Page 6 of 6)

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INDOMETHACIN indomethacin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-536(NDC:31722-542)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDOMETHACIN (INDOMETHACIN) INDOMETHACIN 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM LAURYL SULFATE
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
D&C YELLOW NO. 10
FERROSOFERRIC OXIDE
Product Characteristics
Color GREEN (light green) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code H;103
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55700-536-30 30 CAPSULE in 1 BOTTLE None
2 NDC:55700-536-60 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091240 11/01/2011 11/30/2021
INDOMETHACIN indomethacin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-537(NDC:31722-543)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDOMETHACIN (INDOMETHACIN) INDOMETHACIN 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM LAURYL SULFATE
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
D&C YELLOW NO. 10
FERROSOFERRIC OXIDE
Product Characteristics
Color GREEN (light green) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code H;104
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55700-537-21 21 CAPSULE in 1 BOTTLE None
2 NDC:55700-537-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091240 11/01/2011
Labeler — Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Operations
Lake Erie Medical DBA Quality Care Products LLC 831276758 repack (55700-536), repack (55700-537)

Revised: 01/2022 Lake Erie Medical DBA Quality Care Products LLC

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