ETODOLAC tablet, film coated, extended release

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008)

제공처:

Zydus Lifesciences Limited

INN (국제 이름):

ETODOLAC

구성:

ETODOLAC 400 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Carefully consider the potential benefits and risks of etodolac extended-release tablets, USP and other treatment options before deciding to use etodolac extended-release tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets, USP are indicated: *    For relief of signs and symptoms of juvenile arthritis *    For relief of the signs and symptoms of rheumatoid arthritis *    For relief of the signs and symptoms of osteoarthritis Etodolac extended-release tablets are contraindicated in patients with known hypersensitivity to etodolac. Etodolac extended-release tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions   and PRECAUTIONS, Preexisting Asthma). Etodolac extended-relea

제품 요약:

Etodolac Extended-release Tablets USP, 400 mg are orange-colored, oval-shaped, beveled edged, film-coated tablets, debossed with "271" on one side and plain on other side and are supplied as follows: NDC 65841-777-14 in bottles of 60 tablets NDC 65841-777-01 in bottles of 100 tablets NDC 65841-777-05 in bottles of 500 tablets NDC 65841-777-10 in bottles of 1000 tablets NDC 65841-777-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Etodolac Extended-release Tablets USP, 500 mg are grey-colored, oval-shaped, beveled edged, film-coated tablets, debossed with "272" on one side and plain on other side and are supplied as follows: NDC 65841-778-14 in bottles of 60 tablets NDC 65841-778-01 in bottles of 100 tablets NDC 65841-778-05 in bottles of 500 tablets NDC 65841-778-10 in bottles of 1000 tablets NDC 65841-778-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Etodolac Extended-release Tablets USP, 600 mg are blue-colored, oval-shaped, beveled edged, film-coated tablets debossed with "273" on one side and plain on other side and are supplied as follows: NDC 65841-779-14 in bottles of 60 tablets NDC 65841-779-01 in bottles of 100 tablets NDC 65841-779-05 in bottles of 500 tablets NDC 65841-779-10 in bottles of 1000 tablets NDC 65841-779-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive heat and humidity. Dispense in a tight, light-resistant container with a child-resistant closure.

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

Zydus Lifesciences Limited
----------
SPL MEDGUIDE
Revised: 9/2023
Document Id: 4553e909-a4e2-4d42-b5b1-2c029d8cc817
34391-3
Set id: 0c5f8631-f013-4bbb-b610-0a8a1311844e
Version: 7
Effective Time: 20230926
Zydus Lifesciences Limited

제품 특성 요약

ETODOLAC- ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE
ZYDUS LIFESCIENCES LIMITED
----------
ETODOLAC EXTENDED-RELEASE TABLETS, USP
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-777-14 in bottle of 60 tablets
Etodolac Extended-release Tablets USP, 400 mg
R only
60 tablets
NDC 65841-778-14 in bottle of 60 tablets
Etodolac Extended-release Tablets USP, 500 mg
R only
60 tablets
x
x
NDC 65841-779-14 in bottle of 60 tablets
Etodolac Extended-release Tablets USP, 600 mg
R only
60 tablets
ETODOLAC
etodolac tablet, film coated, extended release
x
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-777
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008)
ETODOLAC
400 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
PRODUCT CHARACTERISTICS
COLOR
ORANGE (ORANGE)
SCORE
no score
SHAPE
OVAL (OVAL)
SIZE
17mm
FLAVOR
IMPRINT CODE
271
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-777-
14
60 in 1 BOTTLE; Type 0: Not a Combination
Product
02/15/2014
2
NDC:65841-777-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
02/15/2014
3
NDC:65841-777-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
02/15/2014
4
NDC:65841-777-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
02/15/2014
5
NDC:65841-777-
77
100 in 1 CARTON
02/15/2014
5
NDC:65841-777-
30
1 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMB