What is NDC 49348-636?

49348-636 is the product NDC for Sunmark childrens loratadine (loratadine), Loratadine 5 mg/5mL solution, listed with the FDA by Strategic Sourcing Services LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Sunmark childrens loratadine (Loratadine).

Strategic Sourcing Services LLC, NDC labeler code 49348. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sunmark childrens loratadine?

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.

Sunmark childrens loratadine NDC 49348-636

NDC codes

FDA NDC Directory

Product NDC (as listed)49348-636Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49348-0636Add 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
49348-636-34	4934806363449348063634	1 BOTTLE in 1 CARTON (49348-636-34) / 120 mL in 1 BOTTLEMarketed from Nov 14, 2012

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): Sunmark childrens loratadineSuffix: childrens loratadine
Generic name (nonproprietary): loratadine
Active ingredients: Loratadine — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Strategic Sourcing Services LLCNDC labeler code 49348
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076805
Marketing start: Aug 20, 2004
Listing expires: Dec 31, 2027
Identifiers: Product ID 49348-636_29a2cbbe-88da-1498-e063-6394a90ac36cSPL ID 29a2cbbe-88da-1498-e063-6394a90ac36cSPL set ID ed94cba7-c2c4-4cbe-9021-f554a51d51f2RxCUI 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

N449348063634 followed by a unit qualifier and the quantity

Package 49348-0636-34. 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 Dec 19, 2024.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing 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 49348-636

What is NDC 49348-636?: 49348-636 is the product NDC for Sunmark childrens loratadine (loratadine), Loratadine 5 mg/5mL solution, listed with the FDA by Strategic Sourcing Services LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sunmark childrens loratadine (Loratadine).
What is the active ingredient?: Loratadine.
Who is the labeler?: Strategic Sourcing Services LLC, NDC labeler code 49348. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sunmark childrens loratadine?: 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 076805

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

FDA NDC Directory listings under ANDA 076805
Product	Strength	Form · route	Labeler	Product NDC
Good Neighbor Pharmacy Childrens Loratadineloratadine	Loratadine 5 mg/5mL	SolutionOral	AmerisourceBergen	24385-531
Childrens Loratadine Sugar Freeloratadine	Loratadine 5 mg/5mL	SolutionOral	Walgreen Company	0363-2131
Loratadine	Loratadine 5 mg/5mL	SolutionOral	STRATEGIC SOURCING SERVICES LLC	70677-1057
Childrens Loratadine Sugar Freeloratadine	Loratadine 5 mg/5mL	SolutionOral	STRATEGIC SOURCING SERVICES LLC	70677-1058
Childrens Loratadineloratadine	Loratadine 5 mg/5mL	SolutionOral	Strategic Sourcing Services LLC	62011-0305
Childrens Loratadineloratadine	Loratadine 5 mg/5mL	SolutionOral	Sun Pharmaceutical Industries, Inc.	51672-2073
childrens allergyloratadine	Loratadine 5 mg/5mL	SolutionOral	Publix Super Markets Inc	56062-092
Childrens Loratadineloratadine	Loratadine 5 mg/5mL	SolutionOral	Sun Pharmaceutical Industries, Inc.	51672-2085
Loratadine	Loratadine 5 mg/5mL	SolutionOral	Cardinal Health, 110 dba LEADER	70000-0125
Childrens Loratadine Sugar Freeloratadine	Loratadine 5 mg/5mL	SolutionOral	Sun Pharmaceutical Industries, Inc.	51672-2131
Childrens Loratadine Sugar Freeloratadine	Loratadine 5 mg/5mL	SolutionOral	H E B	37808-131
Childrens Loratadine Sugar Freeloratadine	Loratadine 5 mg/5mL	SolutionOral	American Sales Company	41520-131
Childrens Loratadine Sugar Freeloratadine	Loratadine 5 mg/5mL	SolutionOral	Preferred Pharmaceuticals Inc.	68788-8286

Sunmark childrens loratadine (Loratadine) NDC 49348-636