FDA.reportPublic FDA data

NDC 50383-779-15 - 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
50383-779
Requested NDC
50383-779-15
Package NDCs from labels
50383-779-15, 50383-779-17, 50383-779-30, 50383-779-31, 50383-779-33, 50383-779-08, 50383-779-16, 50383-779-32
Manufacturer
Akorn | Akorn Operating Company LLC
Effective date
2023-01-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lactulose - Akorn | Akorn Operating Company LLCAkorn | Akorn Operating Company LLC2023-01-17HUMAN PRESCRIPTION DRUG LABEL
Lactulose - Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC2013-10-02HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50383-779-082024-07-30LACTULOSE SOLUTION, USP
50383-779-162024-07-30LACTULOSE SOLUTION, USP
50383-779-172024-07-30LACTULOSE SOLUTION, USP
50383-779-312024-07-30LACTULOSE SOLUTION, USP
50383-779-322024-07-30LACTULOSE SOLUTION, USP
50383-779-332024-07-30LACTULOSE SOLUTION, USP
50383-779-082024-01-30LACTULOSE SOLUTION, USP
50383-779-162024-01-30LACTULOSE SOLUTION, USP
50383-779-172024-01-30LACTULOSE SOLUTION, USP
50383-779-312024-01-30LACTULOSE SOLUTION, USP
50383-779-322024-01-30LACTULOSE SOLUTION, USP
50383-779-332024-01-30LACTULOSE SOLUTION, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-779LACTULOSE SOLUTION [AKORN]9Legacy NDC20230120_19455240-16b6-4e25-a5c9-a6c965e5ec19.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-779-08ML - Milliliter50383-779fde82a52-aa05-4816-8685-c9ff286429df12012-07-24
50383-779-15ML - Milliliter50383-779d29ee989-30d6-4102-ad6d-609458b9908312012-07-24
50383-779-16ML - Milliliter50383-779c348a4fa-126e-458b-87c9-933e9e6ef54d12012-07-24
50383-779-17ML - Milliliter50383-779f3900f5f-ad8a-437a-99ff-47000c02a24812013-05-02
50383-779-30ML - Milliliter50383-77914c0cd30-345a-41b8-9f30-f6ff5b5f5d3a12012-07-24
50383-779-31ML - Milliliter50383-77928c7648a-ae73-4704-87f7-57bb22f0dd6d12013-05-02
50383-779-32ML - Milliliter50383-779548dec33-f807-4a61-96b7-30344bf46b7c12012-07-24
50383-779-33ML - Milliliter50383-779fe2b6e67-526f-4524-93af-209ecdce0d6312013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LACTULOSEACTIVE INGREDIENT9U7D5QH5AELACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
LACTULOSEACTIVE MOIETY9U7D5QH5AELACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
GALACTOSEINACTIVE INGREDIENTX2RN3Q8DNELACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RLACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
LACTULOSEACTIVE INGREDIENT9U7D5QH5AELACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
LACTULOSEACTIVE MOIETY9U7D5QH5AELACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
GALACTOSEINACTIVE INGREDIENTX2RN3Q8DNELACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RLACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]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 1 of 11 · 208 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.