What is NDC 0536-1279?

0536-1279 is the product NDC for Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride, Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Rugby Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride (Cetirizine hydrochloride, Pseudoephedrine hydrochloride).

What is the active ingredient?

Cetirizine hydrochloride, Pseudoephedrine hydrochloride.

Rugby Laboratories, NDC labeler code 0536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride?

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 0536-1279

NDC codes

FDA NDC Directory

Product NDC (as listed)0536-1279Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00536-1279Add 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
0536-1279-12	0053612791200536127912	12 BLISTER PACK in 1 CARTON (0536-1279-12) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 9, 2020
0536-1279-35	0053612793500536127935	24 BLISTER PACK in 1 CARTON (0536-1279-35) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 9, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
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: Rugby LaboratoriesNDC labeler code 0536
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 0536-1279_cf50d4ee-e05e-477a-b543-4ba232e53c80SPL ID cf50d4ee-e05e-477a-b543-4ba232e53c80SPL set ID 5c6ac9a2-4f0a-4297-9b83-988d54598f75RxCUI 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

N400536127912 followed by a unit qualifier and the quantity

Package 00536-1279-12. 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 Feb 12, 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 • 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 0536-1279

What is NDC 0536-1279?: 0536-1279 is the product NDC for Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride, Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Rugby Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride (Cetirizine hydrochloride, Pseudoephedrine hydrochloride).
What is the active ingredient?: Cetirizine hydrochloride, Pseudoephedrine hydrochloride.
Who is the labeler?: Rugby Laboratories, NDC labeler code 0536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride?: 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
Leader Allergy Relief Dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Cardinal Health 110, LLC. dba Leader	70000-0042
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 Hydrochloride NDC 0536-1279