NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0380Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0380Add 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
70000-0380-17000003800114 BLISTER PACK in 1 CARTON (70000-0380-1) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 23, 2018
70000-0380-2700000380021 BOTTLE in 1 CARTON (70000-0380-2) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 13, 2018
70000-0380-4700000380041 BOTTLE in 1 CARTON (70000-0380-4) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 13, 2018

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 all day allergy
Generic name (nonproprietary)
cetirizine hydrochloride
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Tablet, Film coated
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 078336
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 70000-0380_f547a78c-52a9-40c8-b48c-7e76681b9c5dSPL ID f547a78c-52a9-40c8-b48c-7e76681b9c5dSPL set ID ce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddfRxCUI 1014678UNII 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

N470000038001 followed by a unit qualifier and the quantity

Package 70000-0380-01. 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 70000-0380

What is NDC 70000-0380?
70000-0380 is the product NDC for leader all day allergy (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 tablet, film coated, 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 all day allergy (Cetirizine Hydrochloride).
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 all day allergy?
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 078336

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

FDA NDC Directory listings under ANDA 078336
ProductStrengthForm · routeLabelerProduct NDC
24 hour allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-458
all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralRite Aid Corporation11822-1002
All Day Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralHyVee Inc42507-458
allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralWalgreen Company0363-4101
allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSafeway21130-425
allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralH E B37808-583
Allergy Relief Indoor and Outdoor Allergiescetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralCVS Pharmacy59779-458
basic care all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-411
Berkley And Jensen All Day Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralBJWC68391-400
betr remedies all day allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralLive Betr LLC80267-409
CareOne Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralAmerican Sales Company41520-781
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6717
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7510
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5510
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7594
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-194
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0194
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-123
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2162
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralVERITYRX, LLC83939-0003

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