FDA.reportPublic FDA data

NDC 0121-0965-01 - 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
0121-0965
Requested NDC
0121-0965-01
Package NDCs from labels
0121-0965-01, 0121-0965-30
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Effective date
2026-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lactulose - PAI Holdings, LLC dba PAI PharmaPAI Holdings, LLC dba PAI Pharma2026-07-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0965-01Lactulose10 g in 1 POUCHPOWDER, FOR SOLUTION103
0121-0965-30Lactulose30 in 1 CARTONPOWDER, FOR SOLUTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0965LACTULOSE POWDER, FOR SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]3Current NDC, 2 package rows20250321_5ae4b6da-44df-419a-9f2b-8c4d79f635c8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0965-01EA - Each0121-0965942a9bd0-de3e-4517-ad05-14ad0966f64612025-05-14
0121-0965-30EA - Each0121-0965796d24eb-3cb0-48f7-a974-38f33fd30b4312025-05-14

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 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
application number: ANDA217914
ndc (package): 0121-1930-01
ndc (package): 0121-0965-01
ndc (package): 0121-0965-30
ndc (package): 0121-1930-30
ndc (product): 0121-0965
ndc (product): 0121-1930
ndc11 (package): 00121096501
rxcui: 1251194
rxcui: 1251190
spl id: 78330d1b-d8d8-46ab-afcd-3a6362520db6
spl set id: 5ae4b6da-44df-419a-9f2b-8c4d79f635c8
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
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
application number: ANDA217914
rxcui: 1251194
rxcui: 1251190
unii: 9U7D5QH5AE
LACTULOSE CrystallineLACTULOSECumberland Assured Products Inc.59e75426-42ae-4904-941f-009181101a8a2025-09-01Warnings, Adverse reactionsExact identifier
rxcui: 1251194
rxcui: 1251190
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.