NDC Code 43063-929-20 - Indomethacin

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

IndomethacinIndomethacin CAPSULE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
INDOMETHACIN(UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956)	INDOMETHACIN	50 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43063-929-20	20 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	01/09/2019
2	NDC:43063-929-30	30 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	14/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091276	12/22/2010

LABELER - PD-Rx Pharmaceuticals, Inc.(156893695)

REGISTRANT - PD-Rx Pharmaceuticals, Inc.(156893695)

NDC 43063-929-20
API & Excipient Details