desmopressin acetate

Generic: desmopressin acetate

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desmopressin acetate
Generic Name desmopressin acetate
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

desmopressin acetate 40 ug/10mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-461
Product ID 25021-461_1d8f37fc-befe-491a-a90d-f24568660cca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204751
Listing Expiration 2026-12-31
Marketing Start 2018-03-15

Pharmacologic Class

Classes
factor viii activator [epc] increased coagulation factor viii activity [pe] increased coagulation factor viii concentration [pe] vasopressin analog [epc] vasopressins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021461
Hyphenated Format 25021-461

Supplemental Identifiers

RxCUI
849501
UNII
XB13HYU18U

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name desmopressin acetate (source: ndc)
Generic Name desmopressin acetate (source: ndc)
Application Number ANDA204751 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 ug/10mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-461-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

25021-461-10 1 VIAL in 1 CARTON (25021-461-10) / 10 mL in 1 VIAL

Ingredients (1)

desmopressin acetate (40 ug/10mL)

Linked Drug Pages (1)

desmopressin acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "1d8f37fc-befe-491a-a90d-f24568660cca", "openfda": {"unii": ["XB13HYU18U"], "rxcui": ["849501"], "spl_set_id": ["40752c75-d09b-4013-9024-442048145b63"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-461-10)  / 10 mL in 1 VIAL", "package_ndc": "25021-461-10", "marketing_start_date": "20180315"}], "brand_name": "desmopressin acetate", "product_id": "25021-461_1d8f37fc-befe-491a-a90d-f24568660cca", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Factor VIII Activator [EPC]", "Increased Coagulation Factor VIII Activity [PE]", "Increased Coagulation Factor VIII Concentration [PE]", "Vasopressin Analog [EPC]", "Vasopressins [CS]"], "product_ndc": "25021-461", "generic_name": "desmopressin acetate", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "desmopressin acetate", "active_ingredients": [{"name": "DESMOPRESSIN ACETATE", "strength": "40 ug/10mL"}], "application_number": "ANDA204751", "marketing_category": "ANDA", "marketing_start_date": "20180315", "listing_expiration_date": "20261231"}