tolvaptan

Generic: tolvaptan

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

Drug Facts

Product Profile

Brand Name tolvaptan
Generic Name tolvaptan
Labeler endo usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tolvaptan 30 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-770
Product ID 49884-770_73a11064-c070-4323-bb7a-59dd36dc1eee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206119
Listing Expiration 2026-12-31
Marketing Start 2022-03-10

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 49884770
Hyphenated Format 49884-770

Supplemental Identifiers

RxCUI
849827 849833
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 ANDA206119 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (49884-770-54) / 10 TABLET in 1 BLISTER PACK (49884-770-52)
source: ndc

Packages (1)

49884-770-54 1 BLISTER PACK in 1 CARTON (49884-770-54) / 10 TABLET in 1 BLISTER PACK (49884-770-52)

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": "73a11064-c070-4323-bb7a-59dd36dc1eee", "openfda": {"nui": ["N0000193181", "N0000193178"], "unii": ["21G72T1950"], "rxcui": ["849827", "849833"], "spl_set_id": ["5b14ba2b-9f80-41d6-9613-f16d3cf37d25"], "pharm_class_epc": ["Vasopressin V2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Vasopressin V2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (49884-770-54)  / 10 TABLET in 1 BLISTER PACK (49884-770-52)", "package_ndc": "49884-770-54", "marketing_start_date": "20220310"}], "brand_name": "Tolvaptan", "product_id": "49884-770_73a11064-c070-4323-bb7a-59dd36dc1eee", "dosage_form": "TABLET", "pharm_class": ["Vasopressin V2 Receptor Antagonist [EPC]", "Vasopressin V2 Receptor Antagonists [MoA]"], "product_ndc": "49884-770", "generic_name": "Tolvaptan", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolvaptan", "active_ingredients": [{"name": "TOLVAPTAN", "strength": "30 mg/1"}], "application_number": "ANDA206119", "marketing_category": "ANDA", "marketing_start_date": "20220310", "listing_expiration_date": "20261231"}