What is NDC 70000-0772?

70000-0772 is the product NDC for Leader 12Hr Allergy And Congestion Relief, Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Leader 12Hr Allergy And Congestion Relief (Fexofenadine hydrochloride, pseudoephedrine hydrochloride).

What is the active ingredient?

Fexofenadine hydrochloride, Pseudoephedrine 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 12Hr Allergy And Congestion Relief?

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.

NDC 70000-0772

NDC codes

FDA NDC Directory

Product NDC (as listed)70000-0772Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70000-0772Add 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	Copy
70000-0772-1	7000007720170000077201	30 BLISTER PACK in 1 CARTON (70000-0772-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 3, 2026
70000-0772-2	7000007720270000077202	20 BLISTER PACK in 1 CARTON (70000-0772-2) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 3, 2026

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 12Hr Allergy And Congestion Relief
Generic name (nonproprietary): fexofenadine hydrochloride, pseudoephedrine hydrochloride
Active ingredients: Fexofenadine hydrochloride — 60 mg/1Pseudoephedrine hydrochloride — 120 mg/1
Dosage form: Tablet, Film coated, Extended release
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 216792
Marketing start: Aug 3, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 70000-0772_8c252600-738b-4fa3-8d53-ec8a07734d04SPL ID 8c252600-738b-4fa3-8d53-ec8a07734d04SPL set ID 1400014a-2fa6-4a4f-8eb9-85ac049b4b70RxCUI 997406UNII 2S068B75ZU, 6V9V2RYJ8N
Pharmacologic class: Histamine-1 Receptor Antagonist; alpha-Adrenergic Agonist

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

N470000077201 followed by a unit qualifier and the quantity

Package 70000-0772-01. 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 Aug 3, 2026.

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 • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70000-0772

What is NDC 70000-0772?: 70000-0772 is the product NDC for Leader 12Hr Allergy And Congestion Relief, Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Leader 12Hr Allergy And Congestion Relief (Fexofenadine hydrochloride, pseudoephedrine hydrochloride).
What is the active ingredient?: Fexofenadine hydrochloride, Pseudoephedrine 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 12Hr Allergy And Congestion Relief?: 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 216792

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

FDA NDC Directory listings under ANDA 216792
Product	Strength	Form · route	Labeler	Product NDC
Equate Allergy Relief Dfexofenadine hydrochloride, pseudoephedrine hydrochloride	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	WALMART INC.	79903-424
Foster And Thrive Allergy And Congestion Dfexofenadine hydrochloride, pseudoephedrine hydrochloride	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Strategic Sourcing Services LLC	70677-1315
Rugby Allergy Relief Dfexofenadine hydrochloride, pseudoephedrine hydrochloride	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Rugby Laboratories	0536-1491

Leader 12Hr Allergy And Congestion Relief NDC 70000-0772