NDC Code(s) : 43063-929-20, 43063-929-30
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IndomethacinIndomethacin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-929(NDC:68462-302)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDOMETHACIN(UNII: XXE1CET956)
(INDOMETHACIN - UNII:XXE1CET956) 		INDOMETHACIN50 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color green Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code G302;G
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-929-2020 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/09/2019
2NDC:43063-929-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product14/01/2019
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 Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-929)

PRINCIPAL DISPLAY PANEL

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