Desmopressin Acetate
Desmopressin AcetateNasal Solution, 0.01%
Approved
Approval ID
b3b68b3a-aa82-4464-8146-51d27861023d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 18, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Desmopressin Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5602
Application NumberANDA074830
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desmopressin Acetate
Product Specifications
Route of AdministrationNASAL
Effective DateMarch 11, 2011
FDA Product Classification
INGREDIENTS (5)
DESMOPRESSIN ACETATEActive
Quantity: 0.1 mg in 1 mL
Code: XB13HYU18U
Classification: ACTIB
CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT