Micotil 300: Product Information (Page 3 of 3)

Principal Display Panel — 250 mL Bottle label

YL241059C

ELANCO
Micotil™ 300
(tilmicosin injection), 300 mg/mL

INDIVIDUAL BOTTLES FOR SALE OR DISTRIBUTION

Store at or below 86°F (30°C)

Protect from direct sunlight

AH0230

6 x 250 ml Bottles

Conservar a 86°F (30°C)

Proteger de la luz solar directa.

Manufactured for:

Elanco US, Inc.

Greenfield, IN 46140, USA

Approved by FDA under NADA # 140-929

Lot:

EXP:

Figure
(click image for full-size original)
MICOTIL 300
tilmicosin phosphate injection
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-0230
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tilmicosin phosphate (tilmicosin) tilmicosin phosphate 300 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
propylene glycol
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-0230-1 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 100 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (58198-0230-1)
2 NDC:58198-0230-2 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
2 250 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (58198-0230-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA140929 02/19/2010
Labeler — Elanco US Inc. (966985624)
Establishment
Name Address ID/FEI Operations
Norbrook Laboratories Limited 232880554 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Norbrook Laboratories Limited 211218325 PACK, LABEL
Establishment
Name Address ID/FEI Operations
Evonik Corporation 130890994 API MANUFACTURE, PACK, LABEL

Revised: 03/2021 Elanco US Inc.

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