Indomethacin (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

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INDOMETHACIN indomethacin capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-506
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDOMETHACIN (INDOMETHACIN) INDOMETHACIN 75 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
STARCH, CORN
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C YELLOW NO. 5
FD&C RED NO. 40
GELATIN
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
POTASSIUM HYDROXIDE
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SUCROSE
TALC
Product Characteristics
Color white (clear) , blue (translucent) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 506;AMNEAL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-506-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:65162-506-06 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:65162-506-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:65162-506-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:65162-506-11 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
6 NDC:65162-506-50 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091549 12/06/2010
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 123797875 analysis (65162-506), label (65162-506), manufacture (65162-506), pack (65162-506)

Revised: 12/2021 Amneal Pharmaceuticals LLC

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