tolvaptan

Generic: tolvaptan

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

Drug Facts

Product Profile

Brand Name tolvaptan
Generic Name tolvaptan
Labeler lupin pharmaceuticals, inc.
Dosage Form KIT
Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-241
Product ID 70748-241_3e110564-6fd2-4450-a3d2-a5de70b85f2d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216063
Listing Expiration 2026-12-31
Marketing Start 2025-05-12

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 70748241
Hyphenated Format 70748-241

Supplemental Identifiers

RxCUI
2044359 2044363 2044367 2044966 2044968 2044970 2274813 2274815 2719335 2719337
UPC
0370748244135 0370748241134 0370748240137 0370748242131 0370748243138
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 ANDA216063 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 15 mg
  • 30 mg
  • 45 mg
  • 60 mg
  • 90 mg
source: label
Packaging
  • 4 BLISTER PACK in 1 CARTON (70748-241-13) / 1 KIT in 1 BLISTER PACK (70748-241-11)
source: ndc

Packages (1)

70748-241-13 4 BLISTER PACK in 1 CARTON (70748-241-13) / 1 KIT in 1 BLISTER PACK (70748-241-11)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

TOLVAPTAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "3e110564-6fd2-4450-a3d2-a5de70b85f2d", "openfda": {"nui": ["N0000193181", "N0000193178"], "upc": ["0370748244135", "0370748241134", "0370748240137", "0370748242131", "0370748243138"], "unii": ["21G72T1950"], "rxcui": ["2044359", "2044363", "2044367", "2044966", "2044968", "2044970", "2274813", "2274815", "2719335", "2719337"], "spl_set_id": ["9ba38e23-ca66-4406-92af-bbb8fad00e16"], "pharm_class_epc": ["Vasopressin V2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Vasopressin V2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (70748-241-13)  / 1 KIT in 1 BLISTER PACK (70748-241-11)", "package_ndc": "70748-241-13", "marketing_start_date": "20250512"}], "brand_name": "TOLVAPTAN", "product_id": "70748-241_3e110564-6fd2-4450-a3d2-a5de70b85f2d", "dosage_form": "KIT", "product_ndc": "70748-241", "generic_name": "TOLVAPTAN", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOLVAPTAN", "application_number": "ANDA216063", "marketing_category": "ANDA", "marketing_start_date": "20250512", "listing_expiration_date": "20261231"}