Butorphanol Tartrate
Butorphanol Tartrate Nasal Spray, USP CIV Rx only
Approved
Approval ID
5a50d22e-acbe-4b15-9ed6-70713378408a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Butorphanol Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-3090
Application NumberANDA075824
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butorphanol Tartrate
Product Specifications
Route of AdministrationNASAL
Effective DateSeptember 5, 2023
FDA Product Classification
INGREDIENTS (7)
BUTORPHANOL TARTRATEActive
Quantity: 10 mg in 1 mL
Code: 2L7I72RUHN
Classification: ACTIB
BENZETHONIUM CHLORIDEInactive
Code: PH41D05744
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT