NDC Code(s) : 50090-0587-1, 50090-0587-2, 50090-0587-5
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EtodolacEtodolac TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0587(NDC:0093-0892)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETODOLAC(UNII: 2M36281008)
(ETODOLAC - UNII:2M36281008) 		ETODOLAC400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K30(UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 40(UNII: WZB9127XOA)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color PINK Score no score
Shape OVAL (capsule-shaped) Size 19 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-0587-1 20 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
2NDC:50090-0587-2 30 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
3NDC:50090-0587-5 60 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075009 05/20/1998 01/31/2017

PRINCIPAL DISPLAY PANEL

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