tolvaptan

Generic: tolvaptan

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tolvaptan
Generic Name tolvaptan
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tolvaptan 30 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-131
Product ID 72205-131_92ce12f1-eae0-4c83-9a4e-a5181e08fa92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216949
Listing Expiration 2026-12-31
Marketing Start 2023-06-21

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 72205131
Hyphenated Format 72205-131

Supplemental Identifiers

RxCUI
849827 849833
UPC
0372205130111 0372205131118
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 tolvaptan (source: ndc)
Generic Name tolvaptan (source: ndc)
Application Number ANDA216949 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (72205-131-11) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

72205-131-11 1 BLISTER PACK in 1 CARTON (72205-131-11) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

tolvaptan (30 mg/1)

Linked Drug Pages (1)

TOLVAPTAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "92ce12f1-eae0-4c83-9a4e-a5181e08fa92", "openfda": {"nui": ["N0000193181", "N0000193178"], "upc": ["0372205130111", "0372205131118"], "unii": ["21G72T1950"], "rxcui": ["849827", "849833"], "spl_set_id": ["92ce12f1-eae0-4c83-9a4e-a5181e08fa92"], "pharm_class_epc": ["Vasopressin V2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Vasopressin V2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (72205-131-11)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "72205-131-11", "marketing_start_date": "20230926"}], "brand_name": "TOLVAPTAN", "product_id": "72205-131_92ce12f1-eae0-4c83-9a4e-a5181e08fa92", "dosage_form": "TABLET", "pharm_class": ["Vasopressin V2 Receptor Antagonist [EPC]", "Vasopressin V2 Receptor Antagonists [MoA]"], "product_ndc": "72205-131", "generic_name": "TOLVAPTAN", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOLVAPTAN", "active_ingredients": [{"name": "TOLVAPTAN", "strength": "30 mg/1"}], "application_number": "ANDA216949", "marketing_category": "ANDA", "marketing_start_date": "20230621", "listing_expiration_date": "20261231"}