البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
Zydus Lifesciences Limited
LEVOFLOXACIN
LEVOFLOXACIN ANHYDROUS 250 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة