NDC 67877-924-14 - 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: 67877-924
Requested NDC: 67877-924-14
Package NDCs from labels: 67877-924-14, 67877-924-54
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
Label	Manufacturer	Effective date	Type
Tolvaptan - Ascend Laboratories, LLC \| Alkem Laboratories Limited	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2026-08-26	Human 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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolvaptan	TOLVAPTAN	Ascend Laboratories, LLC	82ef58ef-ce46-434e-bf99-89fce51094f1	2026-08-26	Boxed warning, Warnings, Adverse reactions	Exact 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): 67877092414 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
Tolvaptan	TOLVAPTAN	Par Health USA, LLC	5b14ba2b-9f80-41d6-9613-f16d3cf37d25	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 21G72T1950
SAMSCA	TOLVAPTAN	Otsuka America Pharmaceutical, Inc.	5526617c-c7b9-4556-886d-729bbabbc566	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 21G72T1950
TOLVAPTAN	TOLVAPTAN	Northstar Rx LLC	c075d517-f4c8-469a-9f51-416ef61c6a83	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 21G72T1950
Caldesene Baby	STARCH, CORN AND ZINC OXIDE	Insight Pharmaceuticals LLC	9f12dee2-7afa-45e9-a729-0fd42bb77715	2026-04-22	Warnings	Exact identifier unii: O8232NY3SJ
Caldesene Medicated Protecting	CORNSTARCH AND ZINC OXIDE	Insight Pharmaceuticals LLC	ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b	2026-04-22	Warnings	Exact identifier unii: O8232NY3SJ
Lotrimin Daily Sweat and Odor Control	TOPICAL STARCH	Bayer HealthCare LLC.	9ec5c80d-b550-496f-e053-2a95a90a5489	2026-01-16	Warnings	Exact identifier unii: O8232NY3SJ
Medicated Cornstarch Baby Powder	ACTIVE CORN STARCH	Davion, Inc.	e39032d1-c8cd-4a41-af10-126970b8ad38	2025-12-29	Warnings	Exact identifier unii: O8232NY3SJ
Jynarque	TOLVAPTAN	Otsuka America Pharmaceutical, Inc.	3febc0a1-9e5a-4ce0-843d-210f21d862c4	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 2719337 rxcui: 2044966 rxcui: 2274815 rxcui: 2719335 rxcui: 2044359 rxcui: 2274813 rxcui: 2044367 rxcui: 2044968 rxcui: 2044970 rxcui: 2044363 unii: 21G72T1950
TOLVAPTAN	TOLVAPTAN	Lupin Pharmaceuticals, Inc.	9ba38e23-ca66-4406-92af-bbb8fad00e16	2025-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 2719337 rxcui: 2044966 rxcui: 2274815 rxcui: 2719335 rxcui: 2044359 rxcui: 2274813 rxcui: 2044367 rxcui: 2044968 rxcui: 2044970 rxcui: 2044363 unii: 21G72T1950
Tolvaptan	TOLVAPTAN	Teva Pharmaceuticals, Inc.	808a9a1f-2f58-4677-9127-e749ad007094	2025-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 2719337 rxcui: 2044966 rxcui: 2274815 rxcui: 2719335 rxcui: 2044359 rxcui: 2274813 rxcui: 2044367 rxcui: 2044968 rxcui: 2044970 rxcui: 2044363
YVTYVT MICRODERMABRASION FACIAL SCRUB	YVTYVT MICRODERMABRASION FACIAL SCRUB	Beijing JUNGE Technology Co., Ltd.	2f30fc45-42e2-c766-e063-6394a90a8d68	2025-02-28	Warnings	Exact identifier unii: OP1R32D61U
Pure Cornstarch Baby	CORN STARCH	Walgreen Company	d0e9bd13-b568-4f7e-b036-8d23e71ad8bf	2024-03-25	Warnings	Exact identifier unii: O8232NY3SJ
TOLVAPTAN	TOLVAPTAN	Novadoz Pharmaceuticals LLC	92ce12f1-eae0-4c83-9a4e-a5181e08fa92	2023-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 21G72T1950
Tolvaptan	TOLVAPTAN	Ascend Laboratories, LLC	dd71ee70-9435-4715-bee5-edbb5a8d7d7b	2022-09-07	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 2044363 unii: 21G72T1950
Tolvaptan	TOLVAPTAN	Camber Pharmaceuticals, Inc.	6f4c5679-8490-45ec-bd34-1a569e3af850	2022-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 21G72T1950

Reported adverse events (FAERS/openFDA)#

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