etodolac extended-release tablets, usp

etodolac extended-release tablets, usp
SPL v8
SPL
SPL Set ID 0c5f8631-f013-4bbb-b610-0a8a1311844e
Route
oral
Published
Effective Date 2023-09-26
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
etodolac (400 mg)
Inactive Ingredients
d&c yellow no. 10 ethylcellulose (100 mpa.s) fd&c red no. 40 fd&c yellow no. 6 hypromelloses lactose monohydrate magnesium stearate polyethylene glycol, unspecified talc titanium dioxide triacetin sodium phosphate, dibasic, anhydrous fd&c blue no. 2 ferrosoferric oxide ferric oxide yellow ferric oxide red

Identifiers & Packaging

Pill Appearance
Imprint: 273 Shape: oval Color: orange Color: gray Color: blue Size: 17 mm Size: 18 mm Size: 19 mm Score: 1
Marketing Status
anda active Since 2014-02-15

Description

NDC 65841-777-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 400 mg R x only 60 tablets NDC 65841-778-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 500 mg R x only 60 tablets NDC 65841-779-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 600 mg R x only 60 tablets


Medication Information

Description

NDC 65841-777-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 400 mg R x only 60 tablets NDC 65841-778-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 500 mg R x only 60 tablets NDC 65841-779-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 600 mg R x only 60 tablets

Package Label.principal Display Panel

NDC 65841-777-14 in bottle of 60 tablets

Etodolac Extended-release Tablets USP, 400 mg

Rx only

60 tablets

NDC 65841-778-14 in bottle of 60 tablets

Etodolac Extended-release Tablets USP, 500 mg

Rx only

60 tablets

NDC 65841-779-14 in bottle of 60 tablets

Etodolac Extended-release Tablets USP, 600 mg

Rx only

60 tablets


Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 65841-777-14 in bottle of 60 tablets

Etodolac Extended-release Tablets USP, 400 mg

Rx only

60 tablets

NDC 65841-778-14 in bottle of 60 tablets

Etodolac Extended-release Tablets USP, 500 mg

Rx only

60 tablets

NDC 65841-779-14 in bottle of 60 tablets

Etodolac Extended-release Tablets USP, 600 mg

Rx only

60 tablets


Advanced Ingredient Data


Raw Label Data

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