What is NDC 36800-543?

36800-543 is the product NDC for Cetirizine HCl, Cetirizine hydrochloride 10 mg/1 capsule, listed with the FDA by TOP CARE (Topco Associates LLC). It has 2 package NDCs, shown above in 10- and 11-digit form.

TOP CARE (Topco Associates LLC), NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cetirizine HCl?

24 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cetirizine HCl NDC 36800-543 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)36800-543Labeler and product segments. Claims need a package NDC.

Product NDC at billing width36800-0543Add 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
36800-543-15	3680005431536800054315	1 BOTTLE, PLASTIC in 1 CARTON (36800-543-15) / 40 CAPSULE in 1 BOTTLE, PLASTICMarketed from May 30, 2026
36800-543-86	3680005438636800054386	1 BOTTLE, PLASTIC in 1 CARTON (36800-543-86) / 25 CAPSULE in 1 BOTTLE, PLASTICMarketed from May 30, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Cetirizine HCl
Generic name (nonproprietary): cetirizine hcl
Active ingredients: Cetirizine hydrochloride — 10 mg/1
Dosage form: Capsule
Route: Oral
Labeler: TOP CARE (Topco Associates LLC)NDC labeler code 36800
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022429
Marketing start: May 30, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 36800-543_518f25fa-8409-2860-e063-6294a90a4d98SPL ID 518f25fa-8409-2860-e063-6294a90a4d98SPL set ID 3363bd32-cac6-e10c-e063-6294a90a2638RxCUI 1014675UNII 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

N436800054315 followed by a unit qualifier and the quantity

Package 36800-0543-15. 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 May 11, 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 36800-543

What is NDC 36800-543?: 36800-543 is the product NDC for Cetirizine HCl, Cetirizine hydrochloride 10 mg/1 capsule, listed with the FDA by TOP CARE (Topco Associates LLC). It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cetirizine HCl.
What is the active ingredient?: Cetirizine hydrochloride.
Who is the labeler?: TOP CARE (Topco Associates LLC), NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cetirizine HCl?: 24 other product NDCs are listed under this name. See all Cetirizine HCl NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cetirizine HCl NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	CVS Pharmacy	51316-900	51316-0900-19
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	PUBLIX SUPER MARKETS INC	56062-495	56062-0495-86
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	AMERISOURCE BERGEN	46122-815	46122-0815-64
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	WALGREEN COMPANY	0363-6341	00363-6341-1500363-6341-78
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	KROGER COMPANY	59450-020	59450-0020-1559450-0020-86
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	Bionpharma Inc.	69452-479	69452-0479-88
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	Meijer Distribution Inc	79481-0671	79481-0671-02
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	TARGET Corporation	11673-650	11673-0650-15
Cetirizine HClcetirizine	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	GERI-CARE PHARMACEUTICAL CORP	57896-992	57896-0992-01
Cetirizine HClcetirizine	Cetirizine hydrochloride 10 mg/1	TabletOral	Strategic Sourcing Services LLC	70677-1279	70677-1279-0170677-1279-0270677-1279-03+2 more

All 25 Cetirizine HCl NDCs

Other NDCs under NDA 022429

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

FDA NDC Directory listings under NDA 022429
Product	Strength	Form · route	Labeler	Product NDC
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	PUBLIX SUPER MARKETS INC	56062-452
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	Bionpharma Inc.	69452-265
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	PUBLIX SUPER MARKETS INC	56062-495
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	DOLGENCORP INC	55910-784
Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	DISCOUNT DRUG MART, INC.	53943-219
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	TOP CARE (Topco Associates LLC)	36800-542
all day allergycetirizine hcl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	SUPERVALU INC	41163-219
24 Hour Allergycetirizine hcl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	Walgreens	0363-1219
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	KROGER COMPANY	30142-995
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	AMERISOURCE BERGEN	46122-815
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	Bionpharma Inc.	69452-479
Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	Whole Foods Market, INC.	42681-0056
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	TARGET Corporation	11673-650
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	TARGET Corporation	11673-242
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	Meijer Distribution Inc	79481-0671
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	Meijer Distribution Inc	79481-0670
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	Northeast Pharma	80136-856
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	KROGER COMPANY	59450-020
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	CVS Pharmacy	51316-900
Cetirizine HCl	Cetirizine hydrochloride 10 mg/1	CapsuleOral	WALGREEN COMPANY	0363-6341

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