Label: PROMETHAZINE HCL injection, solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 52533-177-78 - Packager: Cantrell Drug Company
- Category: HUMAN PRESCRIPTION DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated August 13, 2014
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL
- SPL UNCLASSIFIED SECTION
-
INGREDIENTS AND APPEARANCE
PROMETHAZINE HCL
promethazine hcl injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-177 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg in 1 mL EDETATE SODIUM (UNII: MP1J8420LU) 0.025 mg in 1 mL CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 0.01 mg in 1 mL SODIUM METABISULFITE (UNII: 4VON5FNS3C) 0.0625 mg in 1 mL PHENOL (UNII: 339NCG44TV) 1.25 mg in 1 mL WATER (UNII: 059QF0KO0R) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain ACETIC ACID (UNII: Q40Q9N063P) May contain SODIUM ACETATE (UNII: 4550K0SC9B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52533-177-78 25 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/29/2014 Labeler - Cantrell Drug Company (035545763)
