tolvaptan

Generic: tolvaptan

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tolvaptan
Generic Name tolvaptan
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tolvaptan 15 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-635
Product ID 67877-635_f75355a8-50ef-4a88-aaa0-c85c0ae5c23d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211891
Listing Expiration 2026-12-31
Marketing Start 2022-09-07

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 67877635
Hyphenated Format 67877-635

Supplemental Identifiers

RxCUI
849827 849833 2044363
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 ANDA211891 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (67877-635-01)
  • 10 TABLET in 1 BOTTLE (67877-635-02)
  • 1 BLISTER PACK in 1 CARTON (67877-635-33) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

67877-635-01 100 TABLET in 1 BOTTLE (67877-635-01) 67877-635-02 10 TABLET in 1 BOTTLE (67877-635-02) 67877-635-33 1 BLISTER PACK in 1 CARTON (67877-635-33) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

tolvaptan (15 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": "f75355a8-50ef-4a88-aaa0-c85c0ae5c23d", "openfda": {"nui": ["N0000193181", "N0000193178"], "unii": ["21G72T1950"], "rxcui": ["849827", "849833", "2044363"], "spl_set_id": ["dd71ee70-9435-4715-bee5-edbb5a8d7d7b"], "pharm_class_epc": ["Vasopressin V2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Vasopressin V2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (67877-635-01)", "package_ndc": "67877-635-01", "marketing_start_date": "20220907"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (67877-635-02)", "package_ndc": "67877-635-02", "marketing_start_date": "20220907"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (67877-635-33)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "67877-635-33", "marketing_start_date": "20220907"}], "brand_name": "Tolvaptan", "product_id": "67877-635_f75355a8-50ef-4a88-aaa0-c85c0ae5c23d", "dosage_form": "TABLET", "pharm_class": ["Vasopressin V2 Receptor Antagonist [EPC]", "Vasopressin V2 Receptor Antagonists [MoA]"], "product_ndc": "67877-635", "generic_name": "Tolvaptan", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolvaptan", "active_ingredients": [{"name": "TOLVAPTAN", "strength": "15 mg/1"}], "application_number": "ANDA211891", "marketing_category": "ANDA", "marketing_start_date": "20220907", "listing_expiration_date": "20261231"}