Over-the-counter drug · ANDA

berkley and jensen clearlax (Polyethylene glycol 3350) NDC 68391-306

Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · BJWC

NDC codes

FDA NDC Directory
Product NDC (as listed)68391-306Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68391-0306Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
68391-306-0268391030602765 g in 1 BOTTLE (68391-306-02)Marketed from Jan 20, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
berkley and jensen clearlax
Generic name (nonproprietary)
polyethylene glycol 3350
Active ingredients
Polyethylene glycol 3350 — 17 g/17g
Dosage form
Powder, For solution
Route
Oral
Labeler
BJWCNDC labeler code 68391
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090685
Marketing start
Listing expires
Other FDA classes
Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers
Product ID 68391-306_a34466ff-3047-4088-9bb5-da3cb0709ae4SPL ID a34466ff-3047-4088-9bb5-da3cb0709ae4
Pharmacologic class
Osmotic Laxative

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468391030602 followed by a unit qualifier and the quantity

Package 68391-0306-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68391-306

What is NDC 68391-306?
68391-306 is the product NDC for berkley and jensen clearlax (polyethylene glycol 3350), Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by BJWC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
berkley and jensen clearlax (Polyethylene Glycol 3350).
What is the active ingredient?
Polyethylene glycol 3350.
Who is the labeler?
BJWC, NDC labeler code 68391. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for berkley and jensen clearlax?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 090685

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090685
ProductStrengthForm · routeLabelerProduct NDC
basic care clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralAmazon.com Services LLC72288-020
basic care clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralAmazon.com Services LLC72288-499
care one clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralAmerican Sales Company41520-306
careone clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralRetail Business Services, LLC72476-723
clear laxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralH E B37808-306
clear laxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralMeijer Distribution Inc41250-306
clear laxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralHyVee Inc42507-306
Clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralSafeway21130-637
clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralPublix Super Markets Inc56062-306
clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralH E B59640-797
Clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralAmazon.com Services LLC72288-033
Clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralAmazon.com Services LLC72288-471
clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralMeijer, Inc.79481-0090
dg health clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralDolgencorp, LLC55910-306
dg health clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralDolgencorp Inc55910-846
Dulcolaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowderOralChattem, Inc.41167-0223
equaline clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralUnited Natural Foods, Inc. dba UNFI41163-306
equate clear laxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralWal-Mart Stores Inc49035-306
Equate ClearLAXpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralWALMART INC.79903-114
Exchange Select ClearLaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralArmy & Air Force Exchange Service55301-306

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