NDC 67877-636

Tolvaptan

Tolvaptan

Tolvaptan is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ascend Laboratories, Llc. The primary component is Tolvaptan.

Product ID67877-636_b6c02c7f-5141-477b-9c07-c6473a9c79fc
NDC67877-636
Product TypeHuman Prescription Drug
Proprietary NameTolvaptan
Generic NameTolvaptan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-05-21
Marketing CategoryANDA / ANDA
Application NumberANDA211891
Labeler NameAscend Laboratories, LLC
Substance NameTOLVAPTAN
Active Ingredient Strength30 mg/1
Pharm ClassesVasopressin V2 Receptor Antagonist [EPC],Vasopressin V2 Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67877-636-01

100 TABLET in 1 BOTTLE (67877-636-01)
Marketing Start Date2020-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67877-636-02 [67877063602]

Tolvaptan TABLET
Marketing CategoryANDA
Application NumberANDA211891
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-21

NDC 67877-636-33 [67877063633]

Tolvaptan TABLET
Marketing CategoryANDA
Application NumberANDA211891
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-21

NDC 67877-636-01 [67877063601]

Tolvaptan TABLET
Marketing CategoryANDA
Application NumberANDA211891
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-21

Drug Details

NDC Crossover Matching brand name "Tolvaptan" or generic name "Tolvaptan"

NDCBrand NameGeneric Name
31722-868TolvaptanTolvaptan
31722-869TolvaptanTolvaptan
49884-768TolvaptanTolvaptan
49884-770TolvaptanTolvaptan
60505-4704TOLVAPTANTOLVAPTAN
60505-4705TOLVAPTANTOLVAPTAN
67877-636TolvaptanTolvaptan
67877-637TolvaptanTolvaptan
59148-079Jynarquetolvaptan
59148-080Jynarquetolvaptan
59148-082JYNARQUEtolvaptan
59148-083JYNARQUEtolvaptan
59148-087Jynarquetolvaptan
59148-088Jynarquetolvaptan
59148-020SAMSCAtolvaptan
59148-021SAMSCAtolvaptan
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