FDA.reportPublic FDA data

NDC 85592-819-01 - LACTULOSE Crystalline

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
85592-819
Requested NDC
85592-819-01
Package NDCs from labels
85592-819-01, 85592-819-30
Manufacturer
Cumberland Assured Products Inc.
Effective date
2025-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LACTULOSE For Oral SolutionCumberland Assured Products Inc.2025-09-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85592-819-01LACTULOSE Crystalline10 g in 1 POUCHPOWDER, FOR SOLUTION102
85592-819-30LACTULOSE Crystalline30 in 1 CARTONPOWDER, FOR SOLUTION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85592-819-01EA - Each85592-819d85656e3-f129-42d5-81a1-ae041ef7a20a12025-12-16
85592-819-30EA - Each85592-819d6000af8-6ac9-496e-854a-b721e95511da12025-12-16

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LactuloseLACTULOSEAmerican Health Packaging8b79d0d6-b9e3-436e-bab7-01451b6f45cd2026-08-17Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
Lactulose SolutionLACTULOSE SOLUTION USP, 10 G/15 MLKesin Pharma Corporation163d5093-e35c-0bbf-e063-6294a90a803e2026-08-03Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
Lactulose SolutionLACTULOSE SOLUTION USP, 10 G/15 MLKesin Pharma Corporation2d90e2a4-334f-ab68-e063-6294a90affa62026-08-03Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LactuloseLACTULOSEAPOZEAL PHARMACEUTICALS INC72ac130a-de85-464d-9e9b-05cac0c54db12026-07-23Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LactuloseLACTULOSEPAI Holdings, LLC dba PAI Pharma5ae4b6da-44df-419a-9f2b-8c4d79f635c82026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 1251194
rxcui: 1251190
unii: 9U7D5QH5AE
LACTULOSELACTULOSECardinal Health 107, LLC3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd72026-05-19Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LactuloseLACTULOSEXttrium Laboratories, Inc.df62ad54-5aba-4d05-e053-2a95a90aa48d2026-04-14Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LactuloseLACTULOSEChartwell RX, LLCd6975cd8-80e0-43e2-809a-175ea7e407152026-01-28Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
Lactulose SolutionLACTULOSE SOLUTION USP, 10 G/15 MLRising Pharma Holdings, Inc.e75c335b-f19e-42e2-a24f-d891a52d3d342026-01-12Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LactuloseLACTULOSEAPOZEAL PHARMACEUTICALS INCa8af7389-3699-4873-b05a-509af7e8eaab2026-01-06Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LactuloseLACTULOSEFoxland Pharmaceuticals, Inc.3363bdbd-f0d1-45b3-8193-7fdb0a310cc22025-12-16Warnings, Adverse reactionsExact identifier
application number: ANDA074712
rxcui: 1251194
rxcui: 1251190
unii: 9U7D5QH5AE
LactuloseLACTULOSEChartwell RX, LLC.bd9f1577-65e8-4521-b176-e5fc60a4a0182025-12-08Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LactuloseLACTULOSEChartwell Governmental & Specialty RX, LLC.887157ba-3c91-4fbf-bb12-b49c6fa4252c2025-11-13Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LACTULOSELACTULOSEAtlantic Biologicals Corp.3fb6e908-893c-5a57-e063-6294a90a1bfc2025-09-26Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LACTULOSELACTULOSEPAI Holdings, LLC dba PAI Pharma0f19e4ed-c90a-4330-a7fa-bf911aa98f092025-09-15Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LACTULOSELACTULOSEPAI Holdings, LLC dba PAI Pharmacbf0497c-9c8d-4dfa-bebd-64c5894684012025-09-15Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LactuloseLACTULOSETrifluent Pharma, Inc.3eaf273a-b49d-2595-e063-6394a90a1cf62025-09-13Warnings, Adverse reactionsExact identifier
rxcui: 1251194
rxcui: 1251190
unii: 9U7D5QH5AE
LACTULOSE CrystallineLACTULOSECumberland Assured Products Inc.59e75426-42ae-4904-941f-009181101a8a2025-09-01Warnings, Adverse reactionsExact identifier
application number: ANDA074712
ndc (package): 85592-829-01
ndc (package): 85592-829-30
ndc (package): 85592-819-30
ndc (package): 85592-819-01
ndc (product): 85592-819
ndc (product): 85592-829
ndc11 (package): 85592081901
rxcui: 1251194
rxcui: 1251190
spl id: ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9
spl set id: 59e75426-42ae-4904-941f-009181101a8a
unii: 9U7D5QH5AE
LactuloseLACTULOSESun Pharmaceutical Industries, Inc.391cfd01-c1fa-41f9-abd7-d0abe9a276342025-08-04Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
EnuloseLACTULOSEBryant Ranch Prepackfa3aae7c-6f98-4fbb-85dc-32affe9874d52024-12-18Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE

Reported adverse events (FAERS/openFDA)#

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