Etodolac (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 400 MG

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

PRINCIPAL DISPLAY PANEL — 400 mg BOTTLE LABEL

NDC 63187-736-20

ETODOLAC TABELTS USP

400 mg

Rx only

20 Tablets

63187-736-2063187-736-20
ETODOLAC etodolac tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-736(NDC:60505-0041)
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
CROSPOVIDONE (120 .MU.M)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
METHYLCELLULOSE (100 MPA.S)
POLYETHYLENE GLYCOL 1600
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code APO;041;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-736-20 20 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:63187-736-30 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:63187-736-60 60 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:63187-736-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076004 05/01/2003
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (63187-736)

Revised: 06/2022 Proficient Rx LP

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