Levofloxacin (Page 17 of 17)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Levofloxacin Tablets, USP

750mg-Bottle of 10 tablets

NDC 12634-674-00

label
(click image for full-size original)
LEVOFLOXACIN levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12634-674(NDC:33342-023)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN (LEVOFLOXACIN ANHYDROUS) LEVOFLOXACIN ANHYDROUS 750 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYSORBATE 80
HYPROMELLOSES
POLYETHYLENE GLYCOLS
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (capsule) Size 22mm
Flavor Imprint Code ML;64
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12634-674-00 10 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:12634-674-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:12634-674-09 35 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:12634-674-12 120 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:12634-674-18 180 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:12634-674-40 40 TABLET, FILM COATED in 1 BOTTLE None
7 NDC:12634-674-42 42 TABLET, FILM COATED in 1 BOTTLE None
8 NDC:12634-674-45 45 TABLET, FILM COATED in 1 BOTTLE None
9 NDC:12634-674-50 50 TABLET, FILM COATED in 1 BOTTLE None
10 NDC:12634-674-52 12 TABLET, FILM COATED in 1 BLISTER PACK None
11 NDC:12634-674-54 14 TABLET, FILM COATED in 1 BLISTER PACK None
12 NDC:12634-674-57 20 TABLET, FILM COATED in 1 BLISTER PACK None
13 NDC:12634-674-59 30 TABLET, FILM COATED in 1 BLISTER PACK None
14 NDC:12634-674-60 60 TABLET, FILM COATED in 1 BOTTLE None
15 NDC:12634-674-61 10 TABLET, FILM COATED in 1 BLISTER PACK None
16 NDC:12634-674-63 3 TABLET, FILM COATED in 1 BLISTER PACK None
17 NDC:12634-674-66 6 TABLET, FILM COATED in 1 BLISTER PACK None
18 NDC:12634-674-67 7 TABLET, FILM COATED in 1 BLISTER PACK None
19 NDC:12634-674-69 9 TABLET, FILM COATED in 1 BLISTER PACK None
20 NDC:12634-674-71 30 TABLET, FILM COATED in 1 BOTTLE None
21 NDC:12634-674-74 24 TABLET, FILM COATED in 1 BOTTLE None
22 NDC:12634-674-78 28 TABLET, FILM COATED in 1 BOTTLE None
23 NDC:12634-674-79 25 TABLET, FILM COATED in 1 BOTTLE None
24 NDC:12634-674-80 20 TABLET, FILM COATED in 1 BOTTLE None
25 NDC:12634-674-81 21 TABLET, FILM COATED in 1 BOTTLE None
26 NDC:12634-674-82 12 TABLET, FILM COATED in 1 BOTTLE None
27 NDC:12634-674-84 14 TABLET, FILM COATED in 1 BOTTLE None
28 NDC:12634-674-85 15 TABLET, FILM COATED in 1 BOTTLE None
29 NDC:12634-674-90 90 TABLET, FILM COATED in 1 BOTTLE None
30 NDC:12634-674-91 1 TABLET, FILM COATED in 1 BLISTER PACK None
31 NDC:12634-674-92 2 TABLET, FILM COATED in 1 BOTTLE None
32 NDC:12634-674-93 3 TABLET, FILM COATED in 1 BOTTLE None
33 NDC:12634-674-94 4 TABLET, FILM COATED in 1 BOTTLE None
34 NDC:12634-674-95 5 TABLET, FILM COATED in 1 BOTTLE None
35 NDC:12634-674-96 6 TABLET, FILM COATED in 1 BOTTLE None
36 NDC:12634-674-97 7 TABLET, FILM COATED in 1 BOTTLE None
37 NDC:12634-674-98 8 TABLET, FILM COATED in 1 BOTTLE None
38 NDC:12634-674-99 9 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200839 03/22/2012
Labeler — Apotheca Inc. (051457844)
Establishment
Name Address ID/FEI Operations
Apotheca Inc. 051457844 repack (12634-674), relabel (12634-674)

Revised: 01/2017 Apotheca Inc.

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