Over-the-counter drug · ANDA

Leader 24HR Allergy Relief (fexofenadine hydrochloride) NDC 70000-0725

Fexofenadine hydrochloride 180 mg/1 · Tablet, Film coated · Oral · Cardinal Health 110, LLC. dba Leader

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0725Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0725Add 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
70000-0725-1700000725011 BOTTLE in 1 CARTON (70000-0725-1) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 1, 2025
70000-0725-2700000725021 BOTTLE in 1 CARTON (70000-0725-2) / 70 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 1, 2025
70000-0725-3700000725031 BOTTLE in 1 CARTON (70000-0725-3) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 1, 2025
70000-0725-47000007250415 BLISTER PACK in 1 CARTON (70000-0725-4) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 1, 2025

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 24HR Allergy Relief
Generic name (nonproprietary)
fexofenadine hydrochloride
Active ingredients
Fexofenadine hydrochloride — 180 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212971
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 70000-0725_c82dd837-c3bd-4762-9b4c-d7ce25393a9bSPL ID c82dd837-c3bd-4762-9b4c-d7ce25393a9bSPL set ID e509800a-e33d-4d22-a6b4-97b7c73b1486RxCUI 997420UNII 2S068B75ZU
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

N470000072501 followed by a unit qualifier and the quantity

Package 70000-0725-01. 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 • itchy, watery eyes • sneezing • itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212971

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

FDA NDC Directory listings under ANDA 212971
ProductStrengthForm · routeLabelerProduct NDC
allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-847
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralWalgreen Company0363-1847
berkley jensen allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralBJWC68391-847
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralPadagis Israel Pharmaceuticals Ltd45802-847
allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralMeijer, Inc.79481-0847
exchange select aller easefexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralArmy & Air Force Exchange Service55301-847
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralKroger Company30142-856
Basic Care Allergyfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-722
Allergyfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-716
allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralHyVee Inc42507-847
dg health aller easefexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralDolgencorp Inc55910-609
kirkland signature aller fexfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralCostco Wholesale Company63981-847
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralCVS Pharmacy69842-914
Basic Care Allergyfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralAmazon.com Services LLC72288-537
careone allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralRetail Business Services, LLC72476-847
basic care allergyfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-847
Hives Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralWalgreen Company0363-4071
topcare allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralTopco Associates LLC36800-691
allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralWalgreen Company0363-7011
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralProficient Rx LP71205-739

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