FDA.reportPublic FDA data

NDC 67877-922-14 - Tolvaptan

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67877-922
Requested NDC
67877-922-14
Package NDCs from labels
67877-922-14, 67877-922-54
Manufacturer
Ascend Laboratories, LLC | Alkem Laboratories Limited
Effective date
2026-08-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tolvaptan - Ascend Laboratories, LLC | Alkem Laboratories LimitedAscend Laboratories, LLC | Alkem Laboratories Limited2026-08-26Human Prescription Drug Label

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TolvaptanTOLVAPTANAscend Laboratories, LLC82ef58ef-ce46-434e-bf99-89fce51094f12026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA220147
ndc (package): 67877-915-30
ndc (package): 67877-922-14
ndc (package): 67877-922-54
ndc (package): 67877-918-30
ndc (package): 67877-920-14
ndc (package): 67877-920-54
ndc (package): 67877-917-30
ndc (package): 67877-921-54
ndc (package): 67877-919-30
ndc (package): 67877-923-54
ndc (package): 67877-921-14
ndc (package): 67877-924-54
ndc (package): 67877-924-14
ndc (package): 67877-916-30
ndc (package): 67877-923-14
ndc (product): 67877-919
ndc (product): 67877-921
ndc (product): 67877-918
ndc (product): 67877-920
ndc (product): 67877-915
ndc (product): 67877-916
ndc (product): 67877-922
ndc (product): 67877-924
ndc (product): 67877-917
ndc (product): 67877-923
ndc11 (package): 67877092214
rxcui: 2719337
rxcui: 2044966
rxcui: 2274815
rxcui: 2719335
rxcui: 2044359
rxcui: 2274813
rxcui: 2044367
rxcui: 2044968
rxcui: 2044970
rxcui: 2044363
spl id: 2a51dd17-fedf-4168-be2a-337ab74667a8
spl set id: 82ef58ef-ce46-434e-bf99-89fce51094f1
unii: 21G72T1950
TolvaptanTOLVAPTANPar Health USA, LLC5b14ba2b-9f80-41d6-9613-f16d3cf37d252026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950
SAMSCATOLVAPTANOtsuka America Pharmaceutical, Inc.5526617c-c7b9-4556-886d-729bbabbc5662026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950
TOLVAPTANTOLVAPTANNorthstar Rx LLCc075d517-f4c8-469a-9f51-416ef61c6a832026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
JynarqueTOLVAPTANOtsuka America Pharmaceutical, Inc.3febc0a1-9e5a-4ce0-843d-210f21d862c42025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2719337
rxcui: 2044966
rxcui: 2274815
rxcui: 2719335
rxcui: 2044359
rxcui: 2274813
rxcui: 2044367
rxcui: 2044968
rxcui: 2044970
rxcui: 2044363
unii: 21G72T1950
TOLVAPTANTOLVAPTANLupin Pharmaceuticals, Inc.9ba38e23-ca66-4406-92af-bbb8fad00e162025-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2719337
rxcui: 2044966
rxcui: 2274815
rxcui: 2719335
rxcui: 2044359
rxcui: 2274813
rxcui: 2044367
rxcui: 2044968
rxcui: 2044970
rxcui: 2044363
unii: 21G72T1950
TolvaptanTOLVAPTANTeva Pharmaceuticals, Inc.808a9a1f-2f58-4677-9127-e749ad0070942025-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2719337
rxcui: 2044966
rxcui: 2274815
rxcui: 2719335
rxcui: 2044359
rxcui: 2274813
rxcui: 2044367
rxcui: 2044968
rxcui: 2044970
rxcui: 2044363
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
TOLVAPTANTOLVAPTANNovadoz Pharmaceuticals LLC92ce12f1-eae0-4c83-9a4e-a5181e08fa922023-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950
TolvaptanTOLVAPTANAscend Laboratories, LLCdd71ee70-9435-4715-bee5-edbb5a8d7d7b2022-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2044363
unii: 21G72T1950
TolvaptanTOLVAPTANCamber Pharmaceuticals, Inc.6f4c5679-8490-45ec-bd34-1a569e3af8502022-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.