FDA.reportPublic FDA data

leader clearlax

Product NDC
70000-0415
11-digit product format
700000415
Labeler code
70000
Product ID
70000-0415_abf92abe-b5f3-4925-823f-5b28d0b15253
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA090685
Marketing category
ANDA
Marketing start
2018-12-27
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/17g
Pharmacologic classes
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
leader clearlax
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P
Rxcui876193, 880407

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0415-1leader clearlax119 g in 1 BOTTLEPOWDER, FOR SOLUTION1195
70000-0415-2leader clearlax238 g in 1 BOTTLEPOWDER, FOR SOLUTION2385
70000-0415-3leader clearlax510 g in 1 BOTTLEPOWDER, FOR SOLUTION5105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0415-1GM - Gram70000-04151690ba08-4a7e-46f2-b879-f933f006fef412019-08-06
70000-0415-2GM - Gram70000-0415c1e19a39-9142-48df-b565-944bc2cdf80012019-09-05
70000-0415-3GM - Gram70000-0415067ef219-0c8f-4031-ae2c-03b5f2b1e16612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0415LEADER CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER]5Current NDC, Legacy NDC, 3 package rows20210617_812c59b0-e7ce-4c7a-91ed-e74b7b1b84be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
880407ClearLax 17 GM Powder for Oral SolutionPSN812c59b0-e7ce-4c7a-91ed-e74b7b1b84be5
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN812c59b0-e7ce-4c7a-91ed-e74b7b1b84be5
880407polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]SBD812c59b0-e7ce-4c7a-91ed-e74b7b1b84be5
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD812c59b0-e7ce-4c7a-91ed-e74b7b1b84be5
880407ClearLax 17 GM Powder for Oral SolutionSY812c59b0-e7ce-4c7a-91ed-e74b7b1b84be5
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY812c59b0-e7ce-4c7a-91ed-e74b7b1b84be5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0415-170000041501119 g in 1 BOTTLE (70000-0415-1) 119 g2018-12-270000-00-00NoNoCurrent
70000-0415-270000041502238 g in 1 BOTTLE (70000-0415-2) 238 g2019-02-190000-00-00NoNoCurrent
70000-0415-370000041503510 g in 1 BOTTLE (70000-0415-3) 510 g2019-01-210000-00-00NoNoCurrent