Advantus: Product Information (Page 2 of 2)

Principal Display Panel — 37.5 mg 30 Tablet Bottle Label

Peel
Here

ORAL FLEA
TREATMENT FOR
DOGS 10 WEEKS
OF AGE AND
OLDER,
BETWEEN
23–110 lbs.

Elanco
advantus ®

(imidacloprid) soft chew

37.5 mg

ORAL FLEA TREATMENT

Starts to kill fleas on dogs
within one hour

30
SOFT
CHEWS

Each soft chew contains 37.5 mg of imidacloprid.

Approved by FDA under NADA # 141-435

KEEP OUT OF REACH OF CHILDREN

Figure
(click image for full-size original)
ADVANTUS imidacloprid tablet, chewable
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-0017
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIDACLOPRID (IMIDACLOPRID) IMIDACLOPRID 7.5 mg
Product Characteristics
Color red (red) Score no score
Shape TRAPEZOID (TRAPEZOID) Size 14mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-0017-1 1 BOTTLE in 1 CARTON contains a BOTTLE (58198-0017-2)
1 NDC:58198-0017-2 7 TABLET, CHEWABLE in 1 BOTTLE This package is contained within the CARTON (58198-0017-1)
2 NDC:58198-0017-3 30 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141435 01/01/2017
ADVANTUS imidacloprid tablet, chewable
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-0018
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIDACLOPRID (IMIDACLOPRID) IMIDACLOPRID 37.5 mg
Product Characteristics
Color red (red) Score no score
Shape TRAPEZOID (TRAPEZOID) Size 14mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-0018-1 1 BOTTLE in 1 CARTON contains a BOTTLE (58198-0018-2)
1 NDC:58198-0018-2 7 TABLET, CHEWABLE in 1 BOTTLE This package is contained within the CARTON (58198-0018-1)
2 NDC:58198-0018-3 30 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141435 01/01/2017
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
Bayer Hispania, S.L. 462205374 API MANUFACTURE

Revised: 05/2021 Elanco US Inc.

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