Allergy (loratadine) NDC 63654-309

NDC codes

FDA NDC Directory

Product NDC (as listed)63654-309Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63654-0309Add 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
63654-309-10	63654030910	1 BLISTER PACK in 1 CARTON (63654-309-10) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 16, 2014

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): Allergy
Generic name (nonproprietary): loratadine
Active ingredients: Loratadine — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Selder, S.A. de C.V.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076471
Marketing start: Dec 16, 2014
Listing expires: Dec 31, 2026
Identifiers: Product ID 63654-309_39201d37-e750-420b-8035-feb97bc77c21SPL ID 39201d37-e750-420b-8035-feb97bc77c21SPL set ID afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251RxCUI 311372UNII 7AJO3BO7QNUPC 0645981000269

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

N463654030910 followed by a unit qualifier and the quantity

Package 63654-0309-10. 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 22, 2016.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ sneezing ■ runny nose ■ 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 076471

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

FDA NDC Directory listings under ANDA 076471
Product	Strength	Form · route	Labeler	Product NDC
Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	Allegiant Health	69168-309
Non-Drowsy Allergy Reliefloratadine tablet	Loratadine 10 mg/1	TabletOral	Lil' Drug Store Products, Inc.	66715-8815