Polyethylene Glycol 3350

Product NDC
72657-196
11-digit product format
726570196
Labeler code
72657
Product ID
72657-196_7c2e19af-e03f-4d48-bac6-2efd716b70b3
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
GLENMARK THERAPEUTICS INC., USA
Application
ANDA203928
Marketing category
ANDA
Marketing start
2024-09-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Polyethylene Glycol 3350
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P
Rxcui876193

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
72657-196-16Polyethylene Glycol 3350765 g in 1 CANPOWDER, FOR SOLUTION7652

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-196-16GM - Gram72657-1967c1d28bb-3268-4b3c-8ffc-460745b073c012026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72657-196POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [GLENMARK THERAPEUTICS INC., USA]1Current NDC, 1 package rows20241204_5aba6bb1-d25d-4901-8e9c-4cd4a3a06471.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN5aba6bb1-d25d-4901-8e9c-4cd4a3a064712
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD5aba6bb1-d25d-4901-8e9c-4cd4a3a064712
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY5aba6bb1-d25d-4901-8e9c-4cd4a3a064712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72657-196-1672657019616765 g in 1 CAN (72657-196-16) 765 g2024-09-19NoNoHistorical