What is NDC 70000-0042?

70000-0042 is the product NDC for Leader Allergy Relief D, Cetirizine hydrochloride 5 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 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Leader Allergy Relief D (Cetirizine hydrochloride, Pseudoephedrine hydrochloride).

What is the active ingredient?

Cetirizine 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 Allergy Relief D?

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 Allergy Relief D NDC 70000-0042

NDC codes

FDA NDC Directory

Product NDC (as listed)70000-0042Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70000-0042Add 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
70000-0042-1	7000000420170000004201	24 BLISTER PACK in 1 CARTON (70000-0042-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 9, 2020

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 Allergy Relief D
Generic name (nonproprietary): cetirizine hydrochloride, pseudoephedrine hydrochloride
Active ingredients: Cetirizine hydrochloride — 5 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 210719
Marketing start: Mar 9, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 70000-0042_57e2382c-9767-4be7-8d6b-db00e13b8276SPL ID 57e2382c-9767-4be7-8d6b-db00e13b8276SPL set ID 3152060c-f613-49db-91d4-356d2070c466RxCUI 1014571UNII 64O047KTOA, 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

N470000004201 followed by a unit qualifier and the quantity

Package 70000-0042-01. 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 Jun 15, 2023.

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 • nasal congestion • 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 70000-0042

What is NDC 70000-0042?: 70000-0042 is the product NDC for Leader Allergy Relief D, Cetirizine hydrochloride 5 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 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Leader Allergy Relief D (Cetirizine hydrochloride, Pseudoephedrine hydrochloride).
What is the active ingredient?: Cetirizine 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 Allergy Relief D?: 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 210719

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

FDA NDC Directory listings under ANDA 210719
Product	Strength	Form · route	Labeler	Product NDC
good sense all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	L. Perrigo Company	0113-0147
allergy relief D12cetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Walgreen Company	0363-4923
topcare all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Topco Associates LLC	36800-744
allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	CVS Pharmacy	69842-415
allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	H E B	37808-651
Foster And Thrive All Day Allergy Dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Strategic Sourcing Services LLC	70677-1311
Cetirizine hydrochloride and Pseudoephedrine hydrochloridecetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Padagis Israel Pharmaceuticals Ltd	45802-147
all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Kroger Company	30142-450
allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Publix Super Markets Inc	56062-147
good neighbor pharmacy all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Amerisource Bergen	46122-626
kirkland signature aller tec dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Costco Wholesale Company	63981-147
Allergy and Sinus Reliefcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Kroger Company	30142-633
allergy relief-Dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Rite Aid Corporation	11822-3009
12 hour allergy dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Meijer Distribution Inc	41250-728
equate allergy relief d nasal decongestantcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	WALMART INC.	79903-126
signature care allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Safeway	21130-644
Allergy Relief D12cetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-607
All Day Allergy Dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	L. Perrigo Company	0113-2147
Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloridecetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Rugby Laboratories	0536-1279