FDA.reportPublic FDA data

NDC 80425-0355-02 - Lubiprostone

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
80425-0355
Requested NDC
80425-0355-02
Package NDCs from labels
80425-0355-2, 80425-0355-02
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lubiprostone - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0355-2Lubiprostone60 in 1 BOTTLECAPSULE, GELATIN COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0355LUBIPROSTONE CAPSULE, GELATIN COATED [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 1 package rows20250101_031149b9-c709-de1f-e063-6394a90a6d81.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0355-2EA - Each80425-0355cb2887e4-96ae-4438-be39-e28ead127c7d12024-06-10

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 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
LubiprostoneLUBIPROSTONEGolden State Medical Supply, Inc.f4d506e0-1322-4fc4-e053-2995a90ac8802026-07-28Warnings, Adverse reactionsExact identifier
application number: NDA021908
rxcui: 794639
rxcui: 616578
unii: 7662KG2R6K
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LubiprostoneLUBIPROSTONESun Pharmaceutical Industries, Inc.f06d76d2-028a-629f-e053-2995a90a80f52026-07-14Warnings, Adverse reactionsExact identifier
application number: NDA021908
ndc (product): 63304-352
rxcui: 794639
rxcui: 616578
spl id: 56918f19-7843-4f63-e063-6294a90a981c
spl set id: f06d76d2-028a-629f-e053-2995a90a80f5
unii: 7662KG2R6K
LubiprostoneLUBIPROSTONEPar Health USA, LLC9d958b58-6c4f-4bb1-8660-cf5eac2564402026-07-10Warnings, Adverse reactionsExact identifier
application number: NDA021908
rxcui: 794639
rxcui: 616578
unii: 7662KG2R6K
LubiprostoneLUBIPROSTONESpecGx LLCcdf79a5a-6857-4a32-8c54-8c435d1a75352026-07-10Warnings, Adverse reactionsExact identifier
application number: NDA021908
rxcui: 794639
rxcui: 616578
unii: 7662KG2R6K
AmitizaLUBIPROSTONESpecGx LLC164a2b47-0a52-4bb4-9e71-5342c2e951f42026-07-10Warnings, Adverse reactionsExact identifier
application number: NDA021908
rxcui: 794639
rxcui: 616578
unii: 7662KG2R6K
LubiprostoneLUBIPROSTONEDr. Reddy's Laboratories Inc.006b8b6c-f0eb-4246-87da-67582984b0e42026-07-10Warnings, Adverse reactionsExact identifier
application number: NDA021908
rxcui: 794639
rxcui: 616578
unii: 7662KG2R6K
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
unii: C9H2L21V7U
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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