MELOXICAM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL)

Disponible desde:

Zydus Lifesciences Limited

Designación común internacional (DCI):

MELOXICAM

Composición:

MELOXICAM 7.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies  (14.1) ]. Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies  (14.1) ]. Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2) ]. Meloxicam is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see Warnings and Precautions (5.7, 5.9) ] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7,5.8) ] - In the setting of coronary ar

Resumen del producto:

Meloxicam Tablets USP, 7.5 mg are yellow, round-shaped, flat beveled edge, uncoated tablets debossed with 'ZC' and '25' on one side and plain on other side and are supplied as follows: NDC 65841-050-16 in bottles of 90 tablets NDC 65841-050-01 in bottles of 100 tablets NDC 65841-050-05 in bottles of 500 tablets NDC 65841-050-40 in bottles of 5000 tablets NDC 65841-050-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Meloxicam Tablets USP, 15 mg are yellow, round-shaped, flat beveled edge, uncoated tablet debossed with 'ZC' and '26' on one side and plain on other side and are supplied as follows: NDC 65841-051-16 in bottles of 90 tablets NDC 65841-051-01 in bottles of 100 tablets NDC 65841-051-05 in bottles of 500 tablets NDC 65841-051-40 in bottles of 5000 tablets NDC 65841-051-77 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]. Keep meloxicam tablets in a dry place. Dispense tablets in a tight container. Keep this and all medications out of the reach of children.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Zydus Lifesciences Limited
----------
SPL MEDGUIDE
Manufactured by:
Cadila Healthcare Ltd.
India.
Revised: 10/2022
Document Id: e2e7eb0f-7da0-45cd-93d8-d49ea6756d73
34391-3
Set id: 5eb2e439-2ef2-496c-9aec-042029ae1305
Version: 7
Effective Time: 20221018
Zydus Lifesciences Limited

Ficha técnica

MELOXICAM - MELOXICAM TABLET
ZYDUS LIFESCIENCES LIMITED
----------
MELOXICAM TABLETS
SPL MEDGUIDE
MANUFACTURED BY:
Cadila Healthcare Ltd.
India.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-050-01 in bottle of 500 tablets
Meloxicam Tablets USP, 7.5 mg
R only
500 tablets
NDC 65841-051-01 in bottle of 500 tablets
Meloxicam Tablets USP, 15 mg
R only
500 tablets
x
x
MELOXICAM
meloxicam tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-050
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL)
MELOXICAM
7.5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (YELLOW)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
Z C;25
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
050-16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
07/19/2006
2
NDC:65841-
050-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
07/19/2006
3
NDC:65841-
050-05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
07/19/2006
4
NDC:65841-
050-40
5000 in 1 BOTTLE; Type 0: Not a Combination
Product
07/19/2006
5
NDC:65841-
050-77
10 in 1 CARTON
07/19/2006
5
NDC:65841-
050-30
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA077921
07/19/2006
MELOXICAM
meloxicam tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-051
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MELOXICAM (UNII: VG