NDC Code(s) : 42211-101-11, 42211-101-01
Packager : Iroko Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

INDOCINindomethacin SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42211-101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDOMETHACIN(UNII: XXE1CET956)
(INDOMETHACIN - UNII:XXE1CET956) 		INDOMETHACIN25 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SORBITOL(UNII: 506T60A25R)
TRAGACANTH(UNII: 2944357O2O)
ALCOHOL(UNII: 3K9958V90M)
SORBIC ACID(UNII: X045WJ989B)
Product Characteristics
Color Score
Shape Size
Flavor PINEAPPLE, COCONUT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42211-101-111 in 1 CARTON 10/10/1985
1237 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:42211-101-011 in 1 CARTON 10/10/1985
250 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018332 10/10/1985

LABELER - Iroko Pharmaceuticals, LLC(796831217)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INDOCIN
(INDOMETHACIN)
ORAL SUSPENSION
25 mg per 5 mL
237 mL

PRINCIPAL DISPLAY PANEL INDOCIN (INDOMETHACIN) ORAL SUSPENSION 25 mg per 5 mL 237 mL