desmopressin acetate

Generic: desmopressin acetate

Labeler: glenmark pharmaceuticals inc.,usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desmopressin acetate
Generic Name desmopressin acetate
Labeler glenmark pharmaceuticals inc.,usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

desmopressin acetate .1 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc.,USA

Identifiers & Regulatory

Product NDC 68462-275
Product ID 68462-275_d9414e03-41d5-4e96-9ce6-b298c365281d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201831
Listing Expiration 2026-12-31
Marketing Start 2015-05-28

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 68462275
Hyphenated Format 68462-275

Supplemental Identifiers

RxCUI
833008 849515
UPC
0368462276013 0368462275016
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 ANDA201831 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68462-275-01)
  • 1000 TABLET in 1 BOTTLE (68462-275-10)
  • 30 TABLET in 1 BOTTLE (68462-275-30)
  • 90 TABLET in 1 BOTTLE (68462-275-90)
source: ndc

Packages (4)

Ingredients (1)

desmopressin acetate (.1 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "d9414e03-41d5-4e96-9ce6-b298c365281d", "openfda": {"upc": ["0368462276013", "0368462275016"], "unii": ["XB13HYU18U"], "rxcui": ["833008", "849515"], "spl_set_id": ["7a26b415-77cd-4b2f-9c76-fa52d2eb6be6"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc.,USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68462-275-01)", "package_ndc": "68462-275-01", "marketing_start_date": "20150528"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68462-275-10)", "package_ndc": "68462-275-10", "marketing_start_date": "20150528"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68462-275-30)", "package_ndc": "68462-275-30", "marketing_start_date": "20150528"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68462-275-90)", "package_ndc": "68462-275-90", "marketing_start_date": "20150528"}], "brand_name": "Desmopressin Acetate", "product_id": "68462-275_d9414e03-41d5-4e96-9ce6-b298c365281d", "dosage_form": "TABLET", "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": "68462-275", "generic_name": "Desmopressin Acetate", "labeler_name": "Glenmark Pharmaceuticals Inc.,USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desmopressin Acetate", "active_ingredients": [{"name": "DESMOPRESSIN ACETATE", "strength": ".1 mg/1"}], "application_number": "ANDA201831", "marketing_category": "ANDA", "marketing_start_date": "20150528", "listing_expiration_date": "20261231"}