What is NDC 51316-503?

51316-503 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, orally disintegrating, listed with the FDA by CVS PHARMACY, INC. It has 6 package NDCs, shown above in 10- and 11-digit form.

CVS PHARMACY, INC, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Loratadine?

109 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Loratadine NDC 51316-503 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51316-503Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51316-0503Add 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
51316-503-01	5131605030151316050301	1 BLISTER PACK in 1 CARTON (51316-503-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Aug 8, 2021
51316-503-02	5131605030251316050302	2 BLISTER PACK in 1 CARTON (51316-503-02) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Aug 8, 2021
51316-503-03	5131605030351316050303	3 BLISTER PACK in 1 CARTON (51316-503-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Aug 8, 2021
51316-503-04	5131605030451316050304	4 BLISTER PACK in 1 CARTON (51316-503-04) / 40 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Aug 8, 2021
51316-503-05	5131605030551316050305	5 BLISTER PACK in 1 CARTON (51316-503-05) / 50 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Aug 8, 2021
51316-503-06	5131605030651316050306	6 BLISTER PACK in 1 CARTON (51316-503-06) / 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Aug 8, 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): Loratadine
Generic name (nonproprietary): loratadine
Active ingredients: Loratadine — 10 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: CVS PHARMACY, INCNDC labeler code 51316
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213294
Marketing start: Aug 8, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 51316-503_0df114fa-ae43-e77d-e063-6294a90a8c36SPL ID 0df114fa-ae43-e77d-e063-6294a90a8c36SPL set ID 7ed2aec0-4da7-4edc-9998-b96c67c82738RxCUI 311373UNII 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

N451316050301 followed by a unit qualifier and the quantity

Package 51316-0503-01. 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 2, 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 51316-503

What is NDC 51316-503?: 51316-503 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, orally disintegrating, listed with the FDA by CVS PHARMACY, INC. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Loratadine.
What is the active ingredient?: Loratadine.
Who is the labeler?: CVS PHARMACY, INC, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Loratadine?: 109 other product NDCs are listed under this name. See all Loratadine 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 Loratadine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Loratadine	Loratadine 10 mg/1	TabletOral	YYBA CORP	73581-229	73581-0229-0173581-0229-03
Loratadine	Loratadine 10 mg/1	TabletOral	AvPAK	50268-777	50268-0777-01
Loratadine	Loratadine 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4103	68788-4103-0068788-4103-0168788-4103-03+2 more
Loratadine	Loratadine 10 mg/1	TabletOral	Safecor Health, LLC	48433-064	48433-0064-20
Loratadine	Loratadine 10 mg/1	TabletOral	Aurobindo Pharma Limited	84386-119	84386-0119-78
Loratadine	Loratadine 10 mg/1	TabletOral	Cabinet Health P.B.C.	82725-0142	82725-0142-0182725-0142-0282725-0142-03+1 more
Loratadine	Loratadine 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0188	55154-0188-00
Loratadine	Loratadine 10 mg/1	TabletOral	Major Pharmaceuticals	0904-7511	00904-7511-61
Loratadine	Loratadine 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8659	68788-8659-0068788-8659-0168788-8659-03+2 more
Loratadine	Loratadine 10 mg/1	Tablet, Orally disintegratingOral	Tenshi Kaizen Pvt Ltd	72983-503	72983-0503-06

All 110 Loratadine NDCs

Other NDCs under ANDA 213294

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

FDA NDC Directory listings under ANDA 213294
Product	Strength	Form · route	Labeler	Product NDC
Alavert Allergyloratadine	Loratadine 10 mg/1	Tablet, Orally disintegratingOral	Foundation Consumer Healthcare	69536-190
Alavert Allergyloratadine	Loratadine 10 mg/1	Tablet, Orally disintegratingOral	Foundation Consumer Healthcare	69536-195
Allervarxloratadine	Loratadine 10 mg/1	Tablet, Orally disintegratingOral	Innovus Pharmaceuticals, Inc.	57483-950
Loratadine	Loratadine 10 mg/1	Tablet, Orally disintegratingOral	Dr. Reddy's Laboratories Inc.	43598-707
Loratadine	Loratadine 10 mg/1	Tablet, Orally disintegratingOral	Dr. Reddy's Laboratories Inc.	43598-758
Loratadine	Loratadine 10 mg/1	Tablet, Orally disintegratingOral	Strides Pharma Inc	59556-917
Loratadine	Loratadine 10 mg/1	Tablet, Orally disintegratingOral	Tenshi Kaizen Pvt Ltd	72983-501
Loratadine	Loratadine 10 mg/1	Tablet, Orally disintegratingOral	Tenshi Kaizen Pvt Ltd	72983-503