desmopressin acetate

Generic: desmopressin acetate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desmopressin acetate
Generic Name desmopressin acetate
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

desmopressin acetate 4 ug/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-550
Product ID 68083-550_0f297b51-3d85-43b9-b96b-88a82858fe3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216922
Listing Expiration 2026-12-31
Marketing Start 2022-11-16

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 68083550
Hyphenated Format 68083-550

Supplemental Identifiers

RxCUI
1723232
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 ANDA216922 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-550-10) / 1 mL in 1 VIAL, SINGLE-DOSE (68083-550-01)
source: ndc

Packages (1)

68083-550-10 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-550-10) / 1 mL in 1 VIAL, SINGLE-DOSE (68083-550-01)

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": "0f297b51-3d85-43b9-b96b-88a82858fe3c", "openfda": {"unii": ["XB13HYU18U"], "rxcui": ["1723232"], "spl_set_id": ["7f4e5a22-85e8-4c28-9ebf-d6ebc75ad653"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (68083-550-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (68083-550-01)", "package_ndc": "68083-550-10", "marketing_start_date": "20221116"}], "brand_name": "Desmopressin Acetate", "product_id": "68083-550_0f297b51-3d85-43b9-b96b-88a82858fe3c", "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": "68083-550", "generic_name": "Desmopressin Acetate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desmopressin Acetate", "active_ingredients": [{"name": "DESMOPRESSIN ACETATE", "strength": "4 ug/mL"}], "application_number": "ANDA216922", "marketing_category": "ANDA", "marketing_start_date": "20221116", "listing_expiration_date": "20261231"}