Label: BUPRENORPHINE injection, solution
BUPRENORPHINE solution
- NDC Code(s): 70022-001-10, 70022-004-10, 70022-010-03, 70022-010-10
- Packager: PAYLESS COMPOUNDERS, LLC
- Category: ANIMAL COMPOUNDED DRUG
- DEA Schedule: CIII
- Marketing Status: unapproved drug other
Drug Label Information
Updated June 27, 2024
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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 20240630-20241231 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) (Source NDC: 38779-0888) 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 BUPRENORPHINE
buprenorphine solutionProduct Information Product Type ANIMAL COMPOUNDED DRUG Item Code (Source) NDC:70022-004 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule CIII Reporting Period 20240630-20241231 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) (Source NDC: 38779-0888) BUPRENORPHINE 0.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) HYDROCHLORIC ACID (UNII: QTT17582CB) BENZYL ALCOHOL (UNII: LKG8494WBH) MANNITOL (UNII: 3OWL53L36A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70022-004-10 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 BUPRENORPHINE
buprenorphine solutionProduct Information Product Type ANIMAL COMPOUNDED DRUG Item Code (Source) NDC:70022-010 Route of Administration ORAL, TRANSMUCOSAL DEA Schedule CIII Reporting Period 20240630-20241231 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) (Source NDC: 38779-0888) BUPRENORPHINE 0.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SUCROSE (UNII: C151H8M554) SODIUM BENZOATE (UNII: OJ245FE5EU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM CITRATE (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70022-010-03 30 mL in 1 BOTTLE, PLASTIC; Number of Units = 30 2 NDC:70022-010-10 100 mL in 1 BOTTLE, PLASTIC; Number of Units = 100 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other Labeler - PAYLESS COMPOUNDERS, LLC (031728341) Establishment Name Address ID/FEI Business Operations PAYLESS COMPOUNDERS, LLC 604160239 outsourcing animal drug compounding
