FDA.reportPublic FDA data

Lactulose Solution

Product NDC
64980-592
11-digit product format
649800592
Labeler code
64980
Product ID
64980-592_ae4387e8-ba31-4378-9e67-98effdcc998f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose Solution USP, 10 g/15 mL
Dosage form
SOLUTION
Route
ORAL; RECTAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA076645
Marketing category
ANDA
Marketing start
2021-10-14
Substance
LACTULOSE
Active strength
10 g/15mL
Pharmacologic classes
Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lactulose Solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACTULOSE10 g/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9U7D5QH5AE
Rxcui391937

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
13620a32-e3b4-4aad-8280-283dce30ddffProduct name120260105
27883b46-af31-44b0-b4ce-e6b4f6d825a7Product name420250812
c1a80c95-0e51-52a0-75fa-75808f51ded8Product name220150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-592-12Lactulose Solution118 mL in 1 BOTTLESOLUTION1183
64980-592-24Lactulose Solution236 mL in 1 BOTTLESOLUTION2363
64980-592-48Lactulose Solution473 mL in 1 BOTTLESOLUTION4733
64980-592-95Lactulose Solution946 mL in 1 BOTTLESOLUTION9463

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-592-48ML - Milliliter64980-59227138c17-a9c7-4b5e-a396-f5f7eef0d1d612023-06-06
64980-592-95ML - Milliliter64980-592166e3dfb-3d9b-40fc-bfbb-c5fa0e4ccc9112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-592LACTULOSE SOLUTION (LACTULOSE SOLUTION USP, 10 G/15 ML) SOLUTION [RISING PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20230602_e75c335b-f19e-42e2-a24f-d891a52d3d34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
391937lactulose 10 GM in 15 mL Oral SolutionPSNe75c335b-f19e-42e2-a24f-d891a52d3d343
391937lactulose 667 MG/ML Oral SolutionSCDe75c335b-f19e-42e2-a24f-d891a52d3d343
391937lactulose 10 GM per 15 ML Oral SolutionSYe75c335b-f19e-42e2-a24f-d891a52d3d343
391937lactulose 20 GM per 30 ML Oral SolutionSYe75c335b-f19e-42e2-a24f-d891a52d3d343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-592-1264980059212118 mL in 1 BOTTLE (64980-592-12) 118 ml2023-05-25NoNoCurrent
64980-592-2464980059224236 mL in 1 BOTTLE (64980-592-24) 236 ml2023-05-25NoNoCurrent
64980-592-4864980059248473 mL in 1 BOTTLE (64980-592-48) 473 ml2023-05-25NoNoCurrent
64980-592-9564980059295946 mL in 1 BOTTLE (64980-592-95) 946 ml2023-05-25NoNoCurrent