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).

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.

leader all day allergy NDC 70000-0380

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 NDC	11-digit (billing)	Package
70000-0380-1	7000003800170000038001	14 BLISTER PACK in 1 CARTON (70000-0380-1) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 23, 2018
70000-0380-2	7000003800270000038002	1 BOTTLE in 1 CARTON (70000-0380-2) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 13, 2018
70000-0380-4	7000003800470000038004	1 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: Aug 13, 2018
Listing expires: Dec 31, 2026
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 Jul 21, 2025.

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
Product	Strength	Form · route	Labeler	Product NDC
Goodnow Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Gobrands, Inc	82501-0422
Cetirizinecetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-0194
Cetirizinecetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-123
allergy reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Safeway	21130-425
rexall all day allergy reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Dolgencorp, LLC	55910-699
All Day Allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	HyVee Inc	42507-458
cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-862
good neighbor pharmacy all day allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Amerisource Bergen	24385-998
cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-343
TopCare All Day Allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Topco Associates LLC	36800-458
Cetirizinecetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7594
equate allergy reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Wal-Mart Stores Inc	49035-458
cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-919
CareOne Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	American Sales Company	41520-781
cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Proficient Rx LP	71205-207
Up and Up Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Target Corporation	11673-502
Exchange select all day allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Army & Air Force Exchange Service	55301-076
Good Sense all day allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7064
Good Sense all day allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7065
Members Mark Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Sam's West Inc	68196-413

Showing 20 of 39.

leader all day allergy (Cetirizine hydrochloride) NDC 70000-0380