Over-the-counter drug · ANDA

Leader Childrens all day allergy (Cetirizine hcl) NDC 70000-0215

Cetirizine hydrochloride 5 mg/5mL · Solution · Oral · Cardinal Health 110, LLC. dba Leader

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0215Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0215Add 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
70000-0215-170000021501700000215011 BOTTLE in 1 CARTON (70000-0215-1) / 118 mL in 1 BOTTLEMarketed from Feb 10, 2017

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 Childrens all day allergy
Generic name (nonproprietary)
cetirizine hcl
Active ingredients
Cetirizine hydrochloride — 5 mg/5mL
Dosage form
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 204226
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 70000-0215_4adfb8b5-ab2e-42de-beda-76bc865afaddSPL ID 4adfb8b5-ab2e-42de-beda-76bc865afaddSPL set ID 6e69ba49-a487-445b-b5f3-5e468d86ac44RxCUI 1014673UNII 64O047KTOA
Pharmacologic class
Histamine-1 Receptor Antagonist

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

N470000021501 followed by a unit qualifier and the quantity

Package 70000-0215-01. 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)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70000-0215

What is NDC 70000-0215?
70000-0215 is the product NDC for Leader Childrens all day allergy (cetirizine hcl), Cetirizine hydrochloride 5 mg/5mL solution, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Leader Childrens all day allergy (Cetirizine HCl).
What is the active ingredient?
Cetirizine hydrochloride.
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 Childrens all day allergy?
1 other product NDC are listed under this name. See all Leader Childrens all day allergy 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 Childrens all day allergy NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Leader Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralCardinal Health 110, LLC. dba Leader70000-021470000-0214-01

Other NDCs under ANDA 204226

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

FDA NDC Directory listings under ANDA 204226
ProductStrengthForm · routeLabelerProduct NDC
Good Neighbor Pharmacy Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralAmerisource Bergen46122-203
childrens all day allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralKroger Company30142-189
Good Sense Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralA-S Medication Solutions50090-7068
childrens allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralWalgreen Company0363-3393
childrens allergy reliefcetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralRite Aid Corporation11822-0475
Members Mark Childrens Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralSam's West Inc68196-475
up and up childrens allergycetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralTarget Corporation82442-475
Basic Care Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralAmazon.com Services LLC72288-330
Equaline childrens all day allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralUnited Natural Foods, Inc. dba UNFI41163-475
Topcare Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralTopco Associates LLC36800-189
Kirkland Signature Childrens Aller Teccetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralCostco Wholesale Company63981-475
Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralAmazon.com Services LLC72288-982
Good Sense Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralL. Perrigo Company0113-0189
foster and thrive childrens allergy reliefcetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralStrategic Sourcing Services LLC70677-1042
Childrens 24 Hour Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralMeijer Distribution Inc41250-475
Childrens Allergy Reliefcetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralCVS Pharmacy59779-509
childrens cetirizine hydrochloridecetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralPreferred Pharmaceuticals Inc.68788-8188
Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralKroger Company30142-475
basic care childrens all day allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralAmazon.com Services LLC72288-475
Welby Childrens Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralAldi Inc64024-475

Showing 20 of 39.

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