NDC 0116-4005-40 - Lactulose

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
0116-4005
Requested NDC
0116-4005-40
Package NDCs from labels
0116-4005-08, 0116-4005-16, 0116-4005-32, 0116-4005-15, 0116-4005-40, 0116-4005-10, 0116-4005-30, 0116-4005-41, 0116-4005-11
Manufacturer
Xttrium Laboratories, Inc.
Effective date
2026-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LACTULOSE SOLUTION, USPXttrium Laboratories, Inc.2026-04-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0116-4005-08Lactulose237 mL in 1 BOTTLESOLUTION2377
0116-4005-10Lactulose100 in 1 CASESOLUTION1007
0116-4005-11Lactulose100 in 1 CASESOLUTION1007
0116-4005-15Lactulose15 mL in 1 CUP, UNIT-DOSESOLUTION157
0116-4005-16Lactulose473 mL in 1 BOTTLESOLUTION4737
0116-4005-30Lactulose30 mL in 1 CUP, UNIT-DOSESOLUTION307
0116-4005-32Lactulose946 mL in 1 BOTTLESOLUTION9467
0116-4005-40Lactulose10 in 1 TRAYSOLUTION107
0116-4005-40Lactulose40 in 1 CASESOLUTION407
0116-4005-41Lactulose40 in 1 CASESOLUTION407
0116-4005-41Lactulose10 in 1 TRAYSOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-4005LACTULOSE SOLUTION [XTTRIUM LABORATORIES, INC.]6Current NDC, Legacy NDC, 11 package rows20250514_df62ad54-5aba-4d05-e053-2a95a90aa48d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0116-4005-08ML - Milliliter0116-4005f7ea2d68-651b-40ae-b2f8-a3eb54ef076f12023-10-16
0116-4005-11ML - Milliliter0116-40056ba03cdd-584d-42d1-9502-0a036d3803df12024-02-14
0116-4005-15ML - Milliliter0116-400511777ba0-6857-4c8d-8508-c3829847a24e12024-02-14
0116-4005-16ML - Milliliter0116-40053451d8c5-188f-4933-aba3-ae2f8e0fdbe512023-04-07
0116-4005-30ML - Milliliter0116-4005f1c0f6c8-48e0-41a6-b878-6217959a472112024-02-14
0116-4005-32ML - Milliliter0116-400523ad189f-3f05-4fb3-b711-3cb594e8928012024-02-14
0116-4005-40ML - Milliliter0116-400569479b61-fb23-48cd-b159-002da8f34bb212024-02-14
0116-4005-41ML - Milliliter0116-40056725bfb2-3713-441f-96d1-afc7805d526312024-02-14

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 · 190 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
LactuloseLACTULOSEAmerican Health Packaging8b79d0d6-b9e3-436e-bab7-01451b6f45cd2026-08-17Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
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
Lactulose SolutionLACTULOSE SOLUTION USP, 10 G/15 MLKesin Pharma Corporation163d5093-e35c-0bbf-e063-6294a90a803e2026-08-03Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
Lactulose SolutionLACTULOSE SOLUTION USP, 10 G/15 MLKesin Pharma Corporation2d90e2a4-334f-ab68-e063-6294a90affa62026-08-03Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
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
LactuloseLACTULOSEAPOZEAL PHARMACEUTICALS INC72ac130a-de85-464d-9e9b-05cac0c54db12026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LactuloseLACTULOSEPAI Holdings, LLC dba PAI Pharma5ae4b6da-44df-419a-9f2b-8c4d79f635c82026-07-07Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
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
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
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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