desmopressin acetate

Generic: desmopressin acetate

Labeler: avenacy, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

desmopressin acetate 4 ug/mL

Manufacturer
Avenacy, Inc.

Identifiers & Regulatory

Product NDC 83634-451
Product ID 83634-451_0181c37e-c05d-47c4-bf3d-126c84bbf063
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210223
Listing Expiration 2026-12-31
Marketing Start 2024-01-15

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 83634451
Hyphenated Format 83634-451

Supplemental Identifiers

RxCUI
849501 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 ANDA210223 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (83634-451-01) / 1 mL in 1 VIAL (83634-451-41)
  • 1 VIAL in 1 CARTON (83634-451-10) / 10 mL in 1 VIAL
source: ndc

Packages (2)

83634-451-01 10 VIAL in 1 CARTON (83634-451-01) / 1 mL in 1 VIAL (83634-451-41) 83634-451-10 1 VIAL in 1 CARTON (83634-451-10) / 10 mL in 1 VIAL

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": "0181c37e-c05d-47c4-bf3d-126c84bbf063", "openfda": {"unii": ["XB13HYU18U"], "rxcui": ["849501", "1723232"], "spl_set_id": ["c2e21331-4d54-4fa7-8f0d-31fe23a981aa"], "manufacturer_name": ["Avenacy, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (83634-451-01)  / 1 mL in 1 VIAL (83634-451-41)", "package_ndc": "83634-451-01", "marketing_start_date": "20240115"}, {"sample": false, "description": "1 VIAL in 1 CARTON (83634-451-10)  / 10 mL in 1 VIAL", "package_ndc": "83634-451-10", "marketing_start_date": "20240115"}], "brand_name": "Desmopressin Acetate", "product_id": "83634-451_0181c37e-c05d-47c4-bf3d-126c84bbf063", "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": "83634-451", "generic_name": "desmopressin acetate", "labeler_name": "Avenacy, 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": "20240115", "listing_expiration_date": "20261231"}