desmopressin acetate

Generic: desmopressin acetate

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desmopressin acetate
Generic Name desmopressin acetate
Labeler dr. reddy's laboratories inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

desmopressin acetate 4 ug/mL

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-053
Product ID 43598-053_58e7affd-0fce-80fb-be3b-7f438f332011
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215961
Listing Expiration 2026-12-31
Marketing Start 2022-09-12

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 43598053
Hyphenated Format 43598-053

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 ANDA215961 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (43598-053-11) / 10 mL in 1 VIAL
source: ndc

Packages (1)

43598-053-11 1 VIAL in 1 CARTON (43598-053-11) / 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": "58e7affd-0fce-80fb-be3b-7f438f332011", "openfda": {"unii": ["XB13HYU18U"], "rxcui": ["849501"], "spl_set_id": ["60dd8694-58d8-d88e-26f2-f28baa53787e"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (43598-053-11)  / 10 mL in 1 VIAL", "package_ndc": "43598-053-11", "marketing_start_date": "20220912"}], "brand_name": "Desmopressin Acetate", "product_id": "43598-053_58e7affd-0fce-80fb-be3b-7f438f332011", "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": "43598-053", "generic_name": "Desmopressin Acetate", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desmopressin Acetate", "active_ingredients": [{"name": "DESMOPRESSIN ACETATE", "strength": "4 ug/mL"}], "application_number": "ANDA215961", "marketing_category": "ANDA", "marketing_start_date": "20220912", "listing_expiration_date": "20261231"}