Etodolac (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 200 mg

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

AvKARE
NDC 42291-404-01
Etodolac Capsules, USP
200mg
100 Capsules Rx Only
PHARMACIST: Dispense the enclosed Medication Guide to each patient.
Each capsule contains 200 mg etodolac.
Store at controlled room temperature 20º to 25ºC
(68º to 77ºF); excursions permitted from 15º to
30ºC (59º to 86ºF) [see USP Controlled Room
Temperature].
Dispense in a tight, light-resistant container [see
USP].
Usual Dosage: See package insert.
KEEP THIS AND ALL DRUGS OUT OF THE REACH
OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 07/16 AV 01/17 (P)
N3 4229140401 4

1
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 300 mg

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

AvKARE
NDC 42291-405-01
Etodolac Capsules, USP
300 mg
100 Capsules Rx Only
Store at controlled room temperature 20º to 25ºC
(68º to 77ºF); excursions permitted from 15º to
30ºC (59º to 86ºF) [see USP Controlled Room
Temperature].
Dispense in a tight, light-resistant container [see
USP].
Usual Dosage: See package insert.
KEEP THIS AND ALL DRUGS OUT OF THE REACH
OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 07/16 AV 01/17 (P)
N3 4229140501 1

2
(click image for full-size original)
ETODOLAC etodolac capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-404(NDC:60505-0039)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETODOLAC (ETODOLAC) ETODOLAC 200 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
GELATIN
LACTOSE MONOHYDRATE
SODIUM LAURYL SULFATE
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (opaque body) , gray (light gray cap) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code APO;039
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-404-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075419 01/05/2017
ETODOLAC etodolac capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-405(NDC:60505-0040)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETODOLAC (ETODOLAC) ETODOLAC 300 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
GELATIN
LACTOSE MONOHYDRATE
SODIUM LAURYL SULFATE
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (opaque body) , gray (light gray cap) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code APO;040
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-405-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075419 01/05/2017
Labeler — AvKARE (796560394)

Revised: 01/2022 AvKARE

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