Childrens Allergy (loratadine) NDC 49035-538

NDC codes

FDA NDC Directory

Product NDC (as listed)49035-538Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49035-0538Add 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
49035-538-08	49035053808	1 BOTTLE in 1 CARTON (49035-538-08) / 120 mL in 1 BOTTLEMarketed from Jun 21, 2019
49035-538-09	49035053809	1 BOTTLE in 1 CARTON (49035-538-09) / 120 mL in 1 BOTTLEMarketed from Mar 7, 2021

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): Childrens Allergy
Generic name (nonproprietary): loratadine
Active ingredients: Loratadine — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Wal-Mart Stores Inc
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201865
Marketing start: Dec 8, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 49035-538_6ee5b7e9-711d-4d18-9cea-09a4d19d4332SPL ID 6ee5b7e9-711d-4d18-9cea-09a4d19d4332SPL set ID 9fb3a3a8-8812-4238-b596-291b79085db9RxCUI 692783UNII 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

N449035053808 followed by a unit qualifier and the quantity

Package 49035-0538-08. 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 Apr 15, 2021.

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)

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
Loratadine	Loratadine 5 mg/5mL	SolutionOral	WALGREEN COMPANY	0363-0771
Childrens Walitinloratadine	Loratadine 5 mg/5mL	SolutionOral	Walgreen Company	0363-2108
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