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 3 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
unii: 1K09F3G675
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
BABY ANTI MONKEY BUTT DIAPER RASHZINC OXIDE, CALAMINEClarion Brands, LLCe4424d74-f89c-5943-42e8-bf3a38e686192025-12-23WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
unii: 1K09F3G675
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
unii: 1K09F3G675
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLAmerisourceBergen Drug Corporationf161e151-4fab-2fbc-e053-2a95a90a54372025-10-30WarningsExact identifier
unii: 1K09F3G675
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLMeijer Distribution Inc.03c46823-0b1f-4101-e063-6294a90aaf942025-10-30WarningsExact identifier
unii: 1K09F3G675
Aveeno Anti-Itch ConcentratedZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC07f4d4d0-9cee-46c3-bc71-2024abd31c9e2025-10-29WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
unii: 1K09F3G675
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
unii: 1K09F3G675
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
unii: 1K09F3G675
Ferrum rosatum GraphitesFERRUM ROSATUM GRAPHITESUriel Pharmacy Inc.1a4ca338-eada-4c0f-8bce-480244940c892025-06-27WarningsExact identifier
unii: 1K09F3G675
AquavitAQUAVITUriel Pharmacy Inc.c1c0887a-c388-c737-e053-2a95a90a076c2025-06-06WarningsExact identifier
unii: 1K09F3G675
TOLVAPTANTOLVAPTANLupin Pharmaceuticals, Inc.9ba38e23-ca66-4406-92af-bbb8fad00e162025-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA216063
ndc (package): 70748-243-13
ndc (package): 70748-242-11
ndc (package): 70748-241-11
ndc (package): 70748-242-13
ndc (package): 70748-240-11
ndc (package): 70748-243-11
ndc (package): 70748-244-11
ndc (package): 70748-244-13
ndc (package): 70748-241-13
ndc (package): 70748-240-13
ndc (package): 70748-239-06
ndc (package): 70748-238-06
ndc (product): 70748-239
ndc (product): 70748-244
ndc (product): 70748-243
ndc (product): 70748-238
ndc (product): 70748-240
ndc (product): 70748-242
ndc (product): 70748-241
ndc11 (package): 70748024311
rxcui: 2719337
rxcui: 2044966
rxcui: 2274815
rxcui: 2719335
rxcui: 2044359
rxcui: 2274813
rxcui: 2044367
rxcui: 2044968
rxcui: 2044970
rxcui: 2044363
spl id: 3e110564-6fd2-4450-a3d2-a5de70b85f2d
spl set id: 9ba38e23-ca66-4406-92af-bbb8fad00e16
unii: 21G72T1950

Reported adverse events (FAERS/openFDA)#

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