LEVOFLOXACIN tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)

Доступна з:

Zydus Lifesciences Limited

ІПН (Міжнародна Ім'я):

LEVOFLOXACIN

Склад:

LEVOFLOXACIN ANHYDROUS 250 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Levofloxacin tablet is indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae . Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)] .   Levofloxacin tablet is indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)] . MDRSP isolat

Огляд продуктів:

Levofloxacin Tablets USP, 250 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC55' on one side and plain on other side and are supplied as follows: NDC 65841-691-18 in bottles of 50 tablets NDC 65841-691-01 in bottles of 100 tablets NDC 65841-691-05 in bottles of 500 tablets Levofloxacin Tablets USP, 500 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC56' on one side and plain on other side and are supplied as follows: NDC 65841-692-18 in bottles of 50 tablets NDC 65841-692-01 in bottles of 100 tablets NDC 65841-692-05 in bottles of 500 tablets NDC 65841-692-10 in bottles of 1000 tablets Levofloxacin Tablets USP, 750 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC57' on one side and plain on other side and are supplied as follows: NDC 65841-693-18 in bottles of 50 tablets NDC 65841-693-01 in bottles of 100 tablets NDC 65841-693-05 in bottles of 500 tablets Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as described in the USP.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Zydus Lifesciences Limited
----------
SPL MEDGUIDE
Revised: 10/2023
Document Id: 15d11e92-6f8b-4c8a-b2b1-90eac26f8e3b
34391-3
Set id: ffa121b8-388f-4d7b-af48-d4aa8d9b5961
Version: 10
Effective Time: 20231004
Zydus Lifesciences Limited

Характеристики продукта

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
LEVOFLOXACIN TABLETS
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-691-18 in bottle of 50 tablets
Levofloxacin Tablets USP, 250 mg
Rx only
50 tablets
NDC 65841-692-18 in bottle of 50 tablets
Levofloxacin Tablets USP, 500 mg
Rx only
50 tablets
NDC 65841-693-18 in bottle of 50 tablets
Levofloxacin Tablets USP, 750 mg
Rx only
50 tablets
LEVOFLOXACIN
levofloxacin tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-691
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS -
UNII:RIX4E89Y14)
LEVOFLOXACIN
ANHYDROUS
250 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
CAPSULE (MODIFIED CAPSULE)
SIZE
15mm
FLAVOR
IMPRINT CODE
Z C55
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-691-
18
50 in 1 BOTTLE; Type 0: Not a Combination
Product
11/10/2012
2
NDC:65841-691-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
11/10/2012
3
NDC:65841-691-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
11/10/2012
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA077652
11/10/2012
LEVOFLOXACIN
levofloxacin tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-692
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS -
UNII:RIX4E89Y14)
LEVOFLOXA