FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
68001-607
Requested package NDC
68001-607-69
11-digit product format
680010607
Labeler code
68001
Product ID
68001-607_12fe5bcd-8ad0-e159-e063-6294a90a444e
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA214990
Marketing category
ANDA
Marketing start
2023-10-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214990-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14
A214990-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2021-04-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14a50c72e98297…
2026-08-01 22:54:322026-06A214990-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2021-04-14a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350YYBA Corp48488531-5d04-4af6-e063-6294a90afe4b2026-01-13WarningsExact identifier
application applno (ANDA): 214990
application number: ANDA214990
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals Inc.cccbe459-813d-4668-8cd2-76be82906a322025-09-09WarningsExact identifier
application applno (ANDA): 214990
application number: ANDA214990
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Camber Consumer Care Incb321a7f5-f80b-4a51-9fd9-2c21fc1cae9b2025-04-23WarningsExact identifier
application applno (ANDA): 214990
application number: ANDA214990
Polyethylene Gycol 3350POLYETHYLENE GYCOL 3350Allegiant Health13851c9a-a226-481b-9db5-bc7053997df72025-03-17WarningsExact identifier
application applno (ANDA): 214990
application number: ANDA214990
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350CHAIN DRUG MARKETING ASSOCIATION, INC.901a1918-87bb-47c2-a465-8c468c3a1ee52024-03-26WarningsExact identifier
application applno (ANDA): 214990
application number: ANDA214990
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350BluePoint Laboratories02e36812-53c2-003b-e063-6394a90aed122024-01-31WarningsExact identifier
application applno (ANDA): 214990
application number: ANDA214990
ndc (package): 68001-607-69
ndc (product): 68001-607
ndc11 (package): 68001060769

Additional Listing Data#

Finished product
Yes
Brand name base
Polyethylene Glycol 3350
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G2M7P15E5PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
876193Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
02e36812-53c2-003b-e063-6394a90aed12Available on FDA.report

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
68001-607-55Polyethylene Glycol 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2382
68001-607-69Polyethylene Glycol 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-607-55GM - Gram68001-607a2aa048a-2c88-428f-b6ca-7e3f063216dc12023-10-16
68001-607-69GM - Gram68001-60791d8a69c-be7f-4a34-8573-08e20d88173912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-607POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [BLUEPOINT LABORATORIES]2Current NDC, 2 package rows20240308_02e36812-53c2-003b-e063-6394a90aed12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN02e36812-53c2-003b-e063-6394a90aed122
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD02e36812-53c2-003b-e063-6394a90aed122
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY02e36812-53c2-003b-e063-6394a90aed122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-607-6968001060769510 g in 1 BOTTLE (68001-607-69) 510 g2023-10-01NoNoCurrent