FDA.reportPublic FDA data

NDC 66220-719-01 - KRISTALOSE

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
66220-719
Requested NDC
66220-719-01
Package NDCs from labels
66220-719-01, 66220-719-30
Manufacturer
Cumberland Pharmaceuticals Inc.
Effective date
2018-09-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
KRISTALOSE - Cumberland Pharmaceuticals Inc.Cumberland Pharmaceuticals Inc.2018-09-17HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66220-719-302022-09-26C16284748780-1e4f33bdf-9f2d-d8a0-e053-dadaa90a6e4eKRISTALOSE ® (lactulose) For Oral Solution Cumberland Pharmaceuticals Inc.
66220-719-302022-07-29C16284748780-1e4f33bdf-9f2d-d8a0-e053-dadaa90a6e4eKRISTALOSE ® (lactulose) For Oral Solution Cumberland Pharmaceuticals Inc.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66220-719-01KRISTALOSE10 g in 1 POUCHPOWDER, FOR SOLUTION104
66220-719-30KRISTALOSE30 in 1 CARTONPOWDER, FOR SOLUTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66220-719KRISTALOSE (LACTULOSE) POWDER, FOR SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20220927_535dd1ea-b567-49f7-9a84-8ea91e78c466.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66220-719-01EA - Each66220-7195ba3d81d-9f5e-4431-ac97-2904210805da12013-08-02
66220-719-30EA - Each66220-719b760842d-4be8-4ad0-a201-ae8232e8bcba12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lactuloseACTIVE INGREDIENT9U7D5QH5AEKRISTALOSE (LACTULOSE) POWDER, FOR SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]1
lactuloseACTIVE MOIETY9U7D5QH5AEKRISTALOSE (LACTULOSE) POWDER, FOR SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]1

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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GenerlacLACTULOSEChartwell RX, LLC35207edd-a5fe-4369-a079-7a8b0d2f2e912024-07-16Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LACTULOSELACTULOSEProficient Rx LP6bbabdc6-f6a8-4f67-a448-e452d1928deb2024-06-01Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
Lactulose SolutionLACTULOSE SOLUTION USP, 10 G/15 MLBajaj Medical, LLCd460b1a2-9091-2ac9-e053-2995a90aa1d22022-12-26Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LactuloseLACTULOSEFresenius Kabi Austria GmbHa89835c9-8ce5-4627-8d7d-70ff175b2e072022-11-09Adverse reactionsExact identifier
unii: 9U7D5QH5AE
ConstuloseLACTULOSEActavis Pharma, Inc.461ec39f-eeb4-4460-9b5c-62367d47162b2022-06-01Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
EnuloseLACTULOSEActavis Pharma, Inc.00c42c5c-d19e-4130-aa08-a8bbd47d3e5b2022-06-01Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
LACTULOSELACTULOSELannett Company, Inc.6619b25c-26b7-4c43-8c4f-9d33a23c61ca2020-01-30Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
KRISTALOSELACTULOSECumberland Pharmaceuticals Inc.535dd1ea-b567-49f7-9a84-8ea91e78c4662018-09-17Warnings, Adverse reactionsExact identifier
application number: ANDA074712
ndc (package): 66220-729-01
ndc (package): 66220-719-01
ndc (package): 66220-729-30
ndc (package): 66220-719-30
ndc (product): 66220-719
ndc (product): 66220-729
ndc11 (package): 66220071901
rxcui: 1251194
rxcui: 1251196
rxcui: 1251192
rxcui: 1251190
spl id: 85528d56-e38f-4565-9136-c7639b479634
spl set id: 535dd1ea-b567-49f7-9a84-8ea91e78c466
unii: 9U7D5QH5AE

Reported adverse events (FAERS/openFDA)#

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