Over-the-counter drug · ANDA

leader clearlax (Polyethylene glycol 3350) NDC 70000-0415

Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Cardinal Health 110, LLC. dba Leader

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0415Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0415Add 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
70000-0415-170000041501119 g in 1 BOTTLE (70000-0415-1)Marketed from Dec 27, 2018
70000-0415-270000041502238 g in 1 BOTTLE (70000-0415-2)Marketed from Feb 19, 2019
70000-0415-370000041503510 g in 1 BOTTLE (70000-0415-3)Marketed from Jan 21, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
leader clearlax
Generic name (nonproprietary)
polyethylene glycol 3350
Active ingredients
Polyethylene glycol 3350 — 17 g/17g
Dosage form
Powder, For solution
Route
Oral
Labeler
Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
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 70000-0415_accc6f85-e45f-408b-861d-3f08f958c637SPL ID accc6f85-e45f-408b-861d-3f08f958c637SPL set ID 812c59b0-e7ce-4c7a-91ed-e74b7b1b84beUNII G2M7P15E5P
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

N470000041501 followed by a unit qualifier and the quantity

Package 70000-0415-01. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70000-0415

What is NDC 70000-0415?
70000-0415 is the product NDC for leader clearlax (polyethylene glycol 3350), Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
leader clearlax (Polyethylene Glycol 3350).
What is the active ingredient?
Polyethylene glycol 3350.
Who is the labeler?
Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for leader clearlax?
1 other product NDC are listed under this name. See all leader clearlax NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other leader clearlax NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Leader ClearLaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralCardinal Health 110, LLC. dba Leader70000-070470000-0704-01

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
berkley and jensen clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralBJWC68391-306
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

Showing 20 of 39.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in