NDC Code(s) : 72578-098-18, 72578-098-01, 72578-098-05, 72578-099-18, 72578-099-01, 72578-099-05, 72578-099-10, 72578-100-18, 72578-100-01, 72578-100-05, 72578-100-92, 72578-100-06
Packager : Viona Pharmaceuticals Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

levofloxacin levofloxacin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-098
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN(UNII: 6GNT3Y5LMF)
(LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) 		LEVOFLOXACIN ANHYDROUS250 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CROSPOVIDONE(UNII: 2S7830E561)
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (MODIFIED CAPSULE) Size 15 mm
Flavor Imprint Code ZC55
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72578-098-1850 in 1 BOTTLE Type 0: Not a Combination Product01/10/2022
2NDC:72578-098-01100 in 1 BOTTLE Type 0: Not a Combination Product01/10/2022
3NDC:72578-098-05500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077652 01/10/2022
levofloxacin levofloxacin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-099
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN(UNII: 6GNT3Y5LMF)
(LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) 		LEVOFLOXACIN ANHYDROUS500 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CROSPOVIDONE(UNII: 2S7830E561)
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (MODIFIED CAPSULE) Size 19 mm
Flavor Imprint Code ZC56
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72578-099-1850 in 1 BOTTLE Type 0: Not a Combination Product01/10/2022
2NDC:72578-099-01100 in 1 BOTTLE Type 0: Not a Combination Product01/10/2022
3NDC:72578-099-05500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2022
4NDC:72578-099-101000 in 1 BOTTLE Type 0: Not a Combination Product01/10/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077652 01/10/2022
levofloxacin levofloxacin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN(UNII: 6GNT3Y5LMF)
(LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) 		LEVOFLOXACIN ANHYDROUS750 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CROSPOVIDONE(UNII: 2S7830E561)
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (MODIFIED CAPSULE) Size 22 mm
Flavor Imprint Code ZC57
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72578-100-1850 in 1 BOTTLE Type 0: Not a Combination Product01/10/2022
2NDC:72578-100-01100 in 1 BOTTLE Type 0: Not a Combination Product01/10/2022
3NDC:72578-100-05500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2022
4NDC:72578-100-9220 in 1 BOTTLE Type 0: Not a Combination Product01/10/2022
5NDC:72578-100-0630 in 1 BOTTLE Type 0: Not a Combination Product01/10/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077652 01/10/2022

LABELER - Viona Pharmaceuticals Inc(081468959)

REGISTRANT - Zydus Lifesciences Limited(918596198)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 918596198 ANALYSIS(72578-098, 72578-099, 72578-100), MANUFACTURE(72578-098, 72578-099, 72578-100)

PRINCIPAL DISPLAY PANEL

NDC 72578-098-18 in bottle of 50 tablets

Levofloxacin Tablets USP, 250 mg

Rx only

50 tablets

Levofloxacin Tablets, 250 mg

NDC 72578-099-18 in bottle of 50 tablets

Levofloxacin Tablets USP, 500 mg

Rx only

50 tablets

Levofloxacin Tablets, 250 mg

NDC 72578-100-92 in bottle of 20 tablets

Levofloxacin Tablets USP, 750 mg

Rx only

20 tablets

Levofloxacin Tablets, 250 mg