jynarque

Generic: tolvaptan

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

Drug Facts

Product Profile

Brand Name jynarque
Generic Name tolvaptan
Labeler otsuka america pharmaceutical, inc.
Dosage Form KIT
Manufacturer
Otsuka America Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 59148-080
Product ID 59148-080_3be8a6fe-a8d0-43ca-a84d-183b522a3cf4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204441
Listing Expiration 2026-12-31
Marketing Start 2020-01-13

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 59148080
Hyphenated Format 59148-080

Supplemental Identifiers

RxCUI
2044355 2044357 2044359 2044361 2044363 2044365 2044367 2044369 2044966 2044967 2044968 2044969 2044970 2044971 2274813 2274814 2274815 2274816 2719335 2719337
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 jynarque (source: ndc)
Generic Name tolvaptan (source: ndc)
Application Number NDA204441 (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 (59148-080-28) / 1 KIT in 1 BLISTER PACK (59148-080-07)
source: ndc

Packages (1)

59148-080-28 4 BLISTER PACK in 1 CARTON (59148-080-28) / 1 KIT in 1 BLISTER PACK (59148-080-07)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Jynarque, JYNARQUE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "3be8a6fe-a8d0-43ca-a84d-183b522a3cf4", "openfda": {"nui": ["N0000193181", "N0000193178"], "unii": ["21G72T1950"], "rxcui": ["2044355", "2044357", "2044359", "2044361", "2044363", "2044365", "2044367", "2044369", "2044966", "2044967", "2044968", "2044969", "2044970", "2044971", "2274813", "2274814", "2274815", "2274816", "2719335", "2719337"], "spl_set_id": ["3febc0a1-9e5a-4ce0-843d-210f21d862c4"], "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": "4 BLISTER PACK in 1 CARTON (59148-080-28)  / 1 KIT in 1 BLISTER PACK (59148-080-07)", "package_ndc": "59148-080-28", "marketing_start_date": "20200113"}], "brand_name": "Jynarque", "product_id": "59148-080_3be8a6fe-a8d0-43ca-a84d-183b522a3cf4", "dosage_form": "KIT", "product_ndc": "59148-080", "generic_name": "tolvaptan", "labeler_name": "Otsuka America Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Jynarque", "application_number": "NDA204441", "marketing_category": "NDA", "marketing_start_date": "20200113", "listing_expiration_date": "20261231"}