Label: BUPRENORPHINE injection, solution
- NDC Code(s): 70022-001-10
- Packager: PAYLESS COMPOUNDERS, LLC
- Category: ANIMAL COMPOUNDED DRUG
- DEA Schedule: CIII
- Marketing Status: unapproved drug other
Drug Label Information
Updated October 29, 2015
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INGREDIENTS AND APPEARANCE
BUPRENORPHINE
buprenorphine injection, solutionProduct Information Product Type ANIMAL COMPOUNDED DRUG Item Code (Source) NDC:70022-001 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule CIII Reporting Period 20151029-20160429 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) BUPRENORPHINE 0.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) MANNITOL (UNII: 3OWL53L36A) WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70022-001-10 10 mL in 1 VIAL, MULTI-DOSE; Number of Units = 10 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/11/2015 Labeler - PAYLESS COMPOUNDERS, LLC (031728341) Establishment Name Address ID/FEI Business Operations PAYLESS COMPOUNDERS, LLC 604160239 outsourcing animal drug compounding