FDA.reportPublic FDA data

NDC 70748-243-11 - 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
70748-243
Requested NDC
70748-243-11
Package NDCs from labels
70748-243-11, 70748-243-13
Manufacturer
Lupin Pharmaceuticals, Inc. | LUPIN LIMITED
Effective date
2025-05-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TOLVAPTAN - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2025-05-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70748-243-11TOLVAPTAN1 in 1 BLISTER PACKKIT16
70748-243-13TOLVAPTAN4 in 1 CARTONKIT46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70748-243TOLVAPTAN ( TOLVAPTAN ) KIT TOLVAPTAN TABLET [LUPIN PHARMACEUTICALS, INC.]6Current NDC, 2 package rows20250513_9ba38e23-ca66-4406-92af-bbb8fad00e16.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70748-243-11EA - Each70748-243b8c52e1d-7d4b-47ad-854b-a06f5adb188912025-06-13
70748-243-13EA - Each70748-24377057a1b-a67e-43d7-93df-52aee5e5d41f12025-06-13

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 4 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 1K09F3G675
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
unii: 1K09F3G675
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
CalamineFERRIC OXIDE REDPreferred Pharmaceuticals Inc.326f3d80-c1bf-4cf0-a662-58e02ed7ee672025-02-12Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Prunus IronPRUNUS IRONUriel Pharmacy Inc.091be588-b62e-4919-8e9e-3edb9792d3192025-01-22WarningsExact identifier
unii: 1K09F3G675
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: 1K09F3G675
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
Ferrum OxydatumFERRUM OXYDATUMHahnemann Laboratories, INC.f8b52d3f-3fe2-a850-e053-6394a90a5d9f2023-04-06Exact identifier
unii: 1K09F3G675
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.