FDA.reportPublic FDA data

CLEARLAX

Product NDC
70677-1068
11-digit product format
706771068
Labeler code
70677
Product ID
70677-1068_374e2998-0c02-c804-e063-6394a90a67c4
Type
HUMAN OTC DRUG
Nonproprietary name
polyethylene glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
STRATEGIC SOURCING SERVICES LLC
Application
ANDA090812
Marketing category
ANDA
Marketing start
2023-08-01
Marketing end
2026-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLEARLAX

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
70677-1068-1CLEARLAX238 g in 1 BOTTLEPOWDER, FOR SOLUTION2382
70677-1068-2CLEARLAX510 g in 1 BOTTLEPOWDER, FOR SOLUTION5102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1068-1GM - Gram70677-106878cd0d06-ad43-4f3f-9a92-94daff08f8fc12023-09-05
70677-1068-2GM - Gram70677-1068e7ce7be6-9876-43c9-a51e-dd1af895ac1a12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1068CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 2 package rows20230830_041157b8-476c-e7d2-e063-6394a90ac3a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
880407ClearLax 17 GM Powder for Oral SolutionPSN041157b8-476c-e7d2-e063-6394a90ac3a02
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN041157b8-476c-e7d2-e063-6394a90ac3a02
880407polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]SBD041157b8-476c-e7d2-e063-6394a90ac3a02
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD041157b8-476c-e7d2-e063-6394a90ac3a02
880407ClearLax 17 GM Powder for Oral SolutionSY041157b8-476c-e7d2-e063-6394a90ac3a02
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY041157b8-476c-e7d2-e063-6394a90ac3a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70677-1068-170677106801238 g in 1 BOTTLE (70677-1068-1) 238 g2023-08-012026-12-31NoNoHistorical
70677-1068-270677106802510 g in 1 BOTTLE (70677-1068-2) 510 g2023-08-012026-06-30NoNoHistorical