desmopressin acetate

Generic: desmopressin acetate

Labeler: xgen pharmaceuticals djb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desmopressin acetate
Generic Name desmopressin acetate
Labeler xgen pharmaceuticals djb, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

desmopressin acetate 4 ug/mL

Manufacturer
XGen Pharmaceuticals DJB, Inc.

Identifiers & Regulatory

Product NDC 39822-6200
Product ID 39822-6200_0ec4ffe1-0ee2-fc69-e063-6394a90ab7fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210223
Listing Expiration 2026-12-31
Marketing Start 2024-03-22

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 398226200
Hyphenated Format 39822-6200

Supplemental Identifiers

RxCUI
849501 1723232
UPC
0339822625017 0339822620012
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 ANDA210223 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (39822-6200-2) / 1 mL in 1 VIAL (39822-6200-1)
source: ndc

Packages (1)

39822-6200-2 10 VIAL in 1 CARTON (39822-6200-2) / 1 mL in 1 VIAL (39822-6200-1)

Ingredients (1)

desmopressin acetate (4 ug/mL)

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": "0ec4ffe1-0ee2-fc69-e063-6394a90ab7fb", "openfda": {"upc": ["0339822625017", "0339822620012"], "unii": ["XB13HYU18U"], "rxcui": ["849501", "1723232"], "spl_set_id": ["1052a869-b64d-655d-e063-6294a90ad0e2"], "manufacturer_name": ["XGen Pharmaceuticals DJB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (39822-6200-2)  / 1 mL in 1 VIAL (39822-6200-1)", "package_ndc": "39822-6200-2", "marketing_start_date": "20240322"}], "brand_name": "Desmopressin Acetate", "product_id": "39822-6200_0ec4ffe1-0ee2-fc69-e063-6394a90ab7fb", "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": "39822-6200", "generic_name": "desmopressin acetate", "labeler_name": "XGen Pharmaceuticals DJB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desmopressin Acetate", "active_ingredients": [{"name": "DESMOPRESSIN ACETATE", "strength": "4 ug/mL"}], "application_number": "ANDA210223", "marketing_category": "ANDA", "marketing_start_date": "20240322", "listing_expiration_date": "20261231"}