Indomethacin (Page 8 of 8)

Principle Display Panel

43063930 Label
(click image for full-size original)
INDOMETHACIN indomethacin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-930(NDC:68462-302)
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
SILICON DIOXIDE
FD&C BLUE NO. 1
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
GELATIN, UNSPECIFIED
D&C YELLOW NO. 10
HYPROMELLOSE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color green Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code G302;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-930-20 20 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091276 12/22/2010
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-930)

Revised: 08/2022 PD-Rx Pharmaceuticals, Inc.

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