Butorphanol Tartrate: Product Information (Page 2 of 2)

Principal Display Panel — 50 mL Carton Label

Butorphanol
Tartrate
Injection

CIV

Contains 10 mg
butorphanol base per mL
as butorphanol tartrate

CAUTION: Federal law restricts
this drug to use by or on the order
of a licensed veterinarian.

Approved by FDA under ANADA #200-322

Net Contents: 50 mL

Principal Display Panel -- 50 mL Carton Label
(click image for full-size original)
BUTORPHANOL TARTRATE
butorphanol tartrate injection
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-0047
Route of Administration INTRAVENOUS DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTORPHANOL TARTRATE (BUTORPHANOL) BUTORPHANOL TARTRATE 10 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-0047-1 1 VIAL in 1 CARTON contains a VIAL (58198-0047-2)
1 NDC:58198-0047-2 50 mL in 1 VIAL This package is contained within the CARTON (58198-0047-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200322 02/15/2015
Labeler — Elanco US Inc. (966985624)
Establishment
Name Address ID/FEI Operations
Elanco US Inc. 117617385 MANUFACTURE, ANALYSIS, PACK, LABEL
Establishment
Name Address ID/FEI Operations
Teva Czech Industries s.r.o 643896244 API MANUFACTURE

Revised: 05/2021 Elanco US Inc.

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