Orbifloxacin: Package Insert and Label Information

ORBIFLOXACIN- orbifloxacin powder
KATAYAMA SEIYAKUSYO CO., LTD.

Principal Display Panel – Drum Label

ORBIFLOXACIN

CAUTION

For manufacturing, processing, or repacking Federal law
restricts this drug to use by or on the order of a licensed
veterinarian. Store at 4°C to 25°C, with excursions up to
40°C.

LOT NO.: GROSS: kg

TARE: kg

RETESTED DATE: NET: kg

KATAYAMA SEIYAKUSYO CO., LTD. TOYAMA PLANT

1-3 Yasuuchi, Yatsuo Machi, Toyama 939-2366, Japan

Principal Display Panel – Drum Label
(click image for full-size original)
ORBIFLOXACIN
orbifloxacin powder
Product Information
Product Type Item Code (Source) NDC:42662-001
Route of Administration NOT APPLICABLE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Orbifloxacin (Orbifloxacin) Orbifloxacin 1 kg in 1 kg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42662-001-01 30 kg in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
bulk ingredient 03/22/2019
Labeler — KATAYAMA SEIYAKUSYO CO., LTD. (693462848)
Establishment
Name Address ID/FEI Operations
KATAYAMA SEIYAKUSHO CO.,LTD. 693462848 API MANUFACTURE

Revised: 01/2022 KATAYAMA SEIYAKUSYO CO., LTD.

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