What is NDC 0363-2108?

0363-2108 is the product NDC for Childrens Walitin (loratadine), Loratadine 5 mg/5mL solution, listed with the FDA by Walgreen Company. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Childrens Walitin (Loratadine).

Walgreen Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Childrens Walitin?

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.

Childrens Walitin NDC 0363-2108 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0363-2108Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00363-2108Add 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
0363-2108-08	00363210808	1 BOTTLE in 1 CARTON (0363-2108-08) / 120 mL in 1 BOTTLEMarketed from Dec 12, 2016

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): Childrens Walitin
Generic name (nonproprietary): loratadine
Active ingredients: Loratadine — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Walgreen CompanyNDC labeler code 0363
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201865
Marketing start: Dec 12, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 0363-2108_ebfab224-98d3-435a-9812-1f16b9b1e8d9SPL ID ebfab224-98d3-435a-9812-1f16b9b1e8d9SPL set ID f7962107-f79a-4a04-af8d-f7b989e51f2cRxCUI 692783, 755478UNII 7AJO3BO7QN

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

N400363210808 followed by a unit qualifier and the quantity

Package 00363-2108-08. 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 Jan 15, 2019.

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 0363-2108

What is NDC 0363-2108?: 0363-2108 is the product NDC for Childrens Walitin (loratadine), Loratadine 5 mg/5mL solution, listed with the FDA by Walgreen Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Childrens Walitin (Loratadine).
What is the active ingredient?: Loratadine.
Who is the labeler?: Walgreen Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Childrens Walitin?: 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 201865

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

FDA NDC Directory listings under ANDA 201865
Product	Strength	Form · route	Labeler	Product NDC
Childrens Loratadine Sugar Freeloratadine	Loratadine 5 mg/5mL	SolutionOral	Sun Pharmaceutical Industries, Inc.	51672-2108
Childrens Allergyloratadine	Loratadine 5 mg/5mL	SolutionOral	CVS Pharmacy	69842-535
Loratadine	Loratadine 5 mg/5mL	SolutionOral	WALGREEN COMPANY	0363-0771
Childrens Allergyloratadine	Loratadine 5 mg/5mL	SolutionOral	Wal-Mart Stores Inc	49035-538

Childrens Walitin (Loratadine) NDC 0363-2108