Store at controlled room temperature 20° to 25°C (68° to 77°F). Discard unused solution after 7 days when stored at room temperature or after 56 days when kept refrigerated. Only use clear solution. Color of solution may vary from colorless to light amber.
TELAZOL (tiletamine and zolazepam for injection) is available in individual vials of 5 mL solution when reconstituted. The addition of 5 mL diluent produces a solution containing the equivalent of 50 mg tiletamine base, 50 mg zolazepam base and 57.7 mg mannitol per milliliter.
10 mL vial -100 mg/mL total (equivalent to 50 mg/mL tiletamine and 50 mg/mL zolazepam) when reconstituted
Approved by FDA under NADA # 106-111
Kalamazoo, MI 49007
Revised: September 2022
PRINCIPAL DISPLAY PANEL — 5 mL Bottle Label
| TELAZOL tiletamine hydrochloride and zolazepam hydrochloride injection, powder, for solution |
|Product Information |
|Product Type ||PRESCRIPTION ANIMAL DRUG ||Item Code (Source) ||NDC:54771-9050 |
|Route of Administration ||INTRAMUSCULAR ||DEA Schedule ||CIII
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|TILETAMINE HYDROCHLORIDE (TILETAMINE) ||TILETAMINE ||50 mg in 1 mL |
|ZOLAZEPAM HYDROCHLORIDE (ZOLAZEPAM) ||ZOLAZEPAM ||50 mg in 1 mL |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| MANNITOL ||57.7 mg in 1 mL |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:54771-9050-1 ||1 BOTTLE in 1 CARTON ||contains a BOTTLE |
| 1 || ||5 mL in 1 BOTTLE ||This package is contained within the CARTON (54771-9050-1) |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|NADA ||NADA106111 ||04/09/1982 || |
|Labeler — Zoetis Inc.
Revised: 09/2023 Zoetis Inc.
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