Etodolac (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC 69238-1342-1

Etodolac Tablets USP, 400 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 69238-1343-1

Etodolac Tablets USP, 500 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

2
(click image for full-size original)
ETODOLAC etodolac tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1342
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETODOLAC (ETODOLAC) ETODOLAC 400 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A CORN
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color orange (peach) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code AC01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1342-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208834 06/11/2018
ETODOLAC etodolac tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1343
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETODOLAC (ETODOLAC) ETODOLAC 500 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A CORN
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
Product Characteristics
Color blue Score no score
Shape OVAL Size 19mm
Flavor Imprint Code AC11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1343-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208834 06/11/2018
Labeler — Amneal Pharmaceuticals NY LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited 650762060 manufacture (69238-1343), manufacture (69238-1342), pack (69238-1343), pack (69238-1342)

Revised: 03/2021 Amneal Pharmaceuticals NY LLC

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