Levofloxacin (Page 15 of 15)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Levofloxacin Tablets, USP
250 mg – Bottle of 50s NDC 33342-021-08

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Levofloxacin Tablets, USP
250 mg – Bottle of 100s NDC 33342-021-11

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Levofloxacin Tablets, USP
500 mg – Bottle of 50s NDC 33342-022-08

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Levofloxacin Tablets, USP
500 mg – Bottle of 100s NDC 33342-022-11

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Levofloxacin Tablets, USP
750 mg – Bottle of 20 Tablets NDC 33342-023-32

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Levofloxacin Tablets, USP
750 mg – Bottle of 100 Tablets NDC 33342-023-11

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LEVOFLOXACIN levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-021
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN (LEVOFLOXACIN ANHYDROUS) LEVOFLOXACIN ANHYDROUS 250 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYSORBATE 80
FERRIC OXIDE RED
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color PINK (pink) Score no score
Shape CAPSULE (capsule) Size 15mm
Flavor Imprint Code ML;62
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-021-08 50 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:33342-021-31 50 TABLET, FILM COATED in 1 BLISTER PACK None
3 NDC:33342-021-12 100 TABLET, FILM COATED in 1 BLISTER PACK None
4 NDC:33342-021-11 100 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 07/31/2025
LEVOFLOXACIN levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-022
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN (LEVOFLOXACIN ANHYDROUS) LEVOFLOXACIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYSORBATE 80
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE (capsule) Size 19mm
Flavor Imprint Code ML;63
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-022-08 50 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:33342-022-31 50 TABLET, FILM COATED in 1 BLISTER PACK None
3 NDC:33342-022-12 100 TABLET, FILM COATED in 1 BLISTER PACK None
4 NDC:33342-022-11 100 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 07/31/2025
LEVOFLOXACIN levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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 GLYCOL, UNSPECIFIED
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:33342-023-32 20 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:33342-023-31 50 TABLET, FILM COATED in 1 BLISTER PACK None
3 NDC:33342-023-12 100 TABLET, FILM COATED in 1 BLISTER PACK None
4 NDC:33342-023-11 100 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 11/30/2025
Labeler — Macleods Pharmaceuticals Limited (862128535)
Establishment
Name Address ID/FEI Operations
Macleods Pharmaceuticals Limited 676369519 ANALYSIS (33342-021), ANALYSIS (33342-022), ANALYSIS (33342-023), LABEL (33342-021), LABEL (33342-022), LABEL (33342-023), MANUFACTURE (33342-021), MANUFACTURE (33342-022), MANUFACTURE (33342-023), PACK (33342-021), PACK (33342-022), PACK (33342-023)

Revised: 02/2023 Macleods Pharmaceuticals Limited

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