FDA.reportPublic FDA data

Generlac

Product NDC
62135-892
11-digit product format
621350892
Labeler code
62135
Product ID
62135-892_1d600b06-58c7-b83e-e063-6294a90a86f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL; RECTAL
Labeler
Chartwell RX, LLC
Application
ANDA074603
Marketing category
ANDA
Marketing start
1996-10-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Generlac
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACTULOSE10 g/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9U7D5QH5AE
Rxcui391937, 544455

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
62135-892-47Generlac473 mL in 1 BOTTLESOLUTION4731
62135-892-94Generlac946 mL in 1 BOTTLESOLUTION9461

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-892-47ML - Milliliter62135-8923779dc56-628e-4fff-a5fa-ee7557cb209412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-892GENERLAC (LACTULOSE) SOLUTION [CHARTWELL RX, LLC]1Current NDC, 2 package rows20240718_35207edd-a5fe-4369-a079-7a8b0d2f2e91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
544455GENERLAC 10 GM in 15 mL Oral SolutionPSN35207edd-a5fe-4369-a079-7a8b0d2f2e911
391937lactulose 10 GM in 15 mL Oral SolutionPSN35207edd-a5fe-4369-a079-7a8b0d2f2e911
544455lactulose 667 MG/ML Oral Solution [Generlac]SBD35207edd-a5fe-4369-a079-7a8b0d2f2e911
391937lactulose 667 MG/ML Oral SolutionSCD35207edd-a5fe-4369-a079-7a8b0d2f2e911
544455Generlac 10 GM per 15 ML Oral SolutionSY35207edd-a5fe-4369-a079-7a8b0d2f2e911
544455Generlac 667 MG/ML Oral SolutionSY35207edd-a5fe-4369-a079-7a8b0d2f2e911
391937lactulose 10 GM per 15 ML Oral SolutionSY35207edd-a5fe-4369-a079-7a8b0d2f2e911
391937lactulose 20 GM per 30 ML Oral SolutionSY35207edd-a5fe-4369-a079-7a8b0d2f2e911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-892-4762135089247473 mL in 1 BOTTLE (62135-892-47) 473 ml2024-07-10NoNoCurrent
62135-892-9462135089294946 mL in 1 BOTTLE (62135-892-94) 946 ml2024-07-10NoNoCurrent