NDC Code(s) : 0986-0512-29
Packager : Elanco Animal Health Co

Category : OTC ANIMAL DRUG LABEL

DEA Schedule : none

Marketing Status : New Animal Drug Application

INGREDIENTS AND APPEARANCE

Component T-H with Tylantrenbolone and tylosin tartrate IMPLANT
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:0986-0512
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
trenbolone acetate(UNII: RUD5Y4SV0S)
(trenbolone - UNII:P53R4420TR) 		trenbolone acetate200 mg
tylosin tartrate(UNII: 5P4625C51T)
(tylosin - UNII:YEF4JXN031) 		tylosin tartrate29 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE K29/32(UNII: 390RMW2PEQ)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0986-0512-295 in 1 CARTON
11 in 1 POUCH
120 in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200224 12/09/2013 05/15/2018

LABELER - Elanco Animal Health Co(807447169)

PRINCIPAL DISPLAY PANEL

Elanco TM

Component ®

Heifers

T - H with Tylan ®

(trenbolone and tylosin implant)

One 20-Dose Cartridge Belt

Principal Display Panel - Pouch Label

PRINCIPAL DISPLAY PANEL

Elanco TM

Component ®

Heifers

T - H with Tylan ®

(trenbolone and tylosin implant)

100 IMPLANTS

Principal Display Panel - Carton Label