samsca

Generic: tolvaptan

Labeler: otsuka america pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name samsca
Generic Name tolvaptan
Labeler otsuka america pharmaceutical, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tolvaptan 30 mg/1

Manufacturer
Otsuka America Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 59148-021
Product ID 59148-021_701668e3-9542-46eb-b6c9-f7553d33385d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022275
Listing Expiration 2026-12-31
Marketing Start 2009-05-19

Pharmacologic Class

Established (EPC)
vasopressin v2 receptor antagonist [epc]
Mechanism of Action
vasopressin v2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59148021
Hyphenated Format 59148-021

Supplemental Identifiers

RxCUI
849827 849831 849833 849835
UNII
21G72T1950
NUI
N0000193181 N0000193178

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 samsca (source: ndc)
Generic Name tolvaptan (source: ndc)
Application Number NDA022275 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (59148-021-50) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

59148-021-50 1 BLISTER PACK in 1 CARTON (59148-021-50) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

tolvaptan (30 mg/1)

Linked Drug Pages (1)

SAMSCA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "701668e3-9542-46eb-b6c9-f7553d33385d", "openfda": {"nui": ["N0000193181", "N0000193178"], "unii": ["21G72T1950"], "rxcui": ["849827", "849831", "849833", "849835"], "spl_set_id": ["5526617c-c7b9-4556-886d-729bbabbc566"], "pharm_class_epc": ["Vasopressin V2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Vasopressin V2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Otsuka America Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59148-021-50)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "59148-021-50", "marketing_start_date": "20090519"}], "brand_name": "SAMSCA", "product_id": "59148-021_701668e3-9542-46eb-b6c9-f7553d33385d", "dosage_form": "TABLET", "pharm_class": ["Vasopressin V2 Receptor Antagonist [EPC]", "Vasopressin V2 Receptor Antagonists [MoA]"], "product_ndc": "59148-021", "generic_name": "tolvaptan", "labeler_name": "Otsuka America Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SAMSCA", "active_ingredients": [{"name": "TOLVAPTAN", "strength": "30 mg/1"}], "application_number": "NDA022275", "marketing_category": "NDA", "marketing_start_date": "20090519", "listing_expiration_date": "20261231"}