What is NDC 63981-724?

63981-724 is the product NDC for KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release, Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 tablet, extended release, listed with the FDA by Kirkland-COSTCO WHOLESALE COMPANY. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release (Loratadine and pseudoephedrine sulfate).

What is the active ingredient?

Loratadine, Pseudoephedrine sulfate.

Kirkland-COSTCO WHOLESALE COMPANY, NDC labeler code 63981. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release?

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.

NDC 63981-724

NDC codes

FDA NDC Directory

Product NDC (as listed)63981-724Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63981-0724Add 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
63981-724-15	6398107241563981072415	1 BLISTER PACK in 1 CARTON (63981-724-15) / 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 25, 2017

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): KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended ReleaseSuffix: Extended Release
Generic name (nonproprietary): loratadine and pseudoephedrine sulfate
Active ingredients: Loratadine — 10 mg/1Pseudoephedrine sulfate — 240 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Kirkland-COSTCO WHOLESALE COMPANYNDC labeler code 63981
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076557
Marketing start: Aug 25, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)
Identifiers: Product ID 63981-724_ebc90414-74b9-4186-99af-b1e655f177ebSPL ID ebc90414-74b9-4186-99af-b1e655f177ebSPL set ID b8e35d9f-5ad7-4cd5-b359-18f7dfe586c6RxCUI 1117562, 1369756UNII 7AJO3BO7QN, Y9DL7QPE6B
Pharmacologic class: alpha-Adrenergic Agonist

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

N463981072415 followed by a unit qualifier and the quantity

Package 63981-0724-15. 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 Aug 23, 2023.

Indications (excerpt from the label)

Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily restores freer breathing through the nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63981-724

What is NDC 63981-724?: 63981-724 is the product NDC for KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release, Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 tablet, extended release, listed with the FDA by Kirkland-COSTCO WHOLESALE COMPANY. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release (Loratadine and pseudoephedrine sulfate).
What is the active ingredient?: Loratadine, Pseudoephedrine sulfate.
Who is the labeler?: Kirkland-COSTCO WHOLESALE COMPANY, NDC labeler code 63981. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release?: 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 076557

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

FDA NDC Directory listings under ANDA 076557
Product	Strength	Form · route	Labeler	Product NDC
Loratadine and Pseudoephedrine Sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Film coated, Extended releaseOral	STRATEGIC SOURCING SERVICES	49348-543
Loratadine and Pseudoephedrine Sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Film coated, Extended releaseOral	Safeway Inc.	21130-724
Loratadine and Pseudoephedrine Sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Film coated, Extended releaseOral	Major Pharmaceuticals	0904-5833
Loratadine and Pseudoephedrine	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Film coated, Extended releaseOral	Walgreen Company	0363-0725
Loratadine and Pseudoephedrine	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Extended releaseOral	AMERISOURCE BERGEN	46122-383
Loratadine and Pseudoephedrine	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Extended releaseOral	STRATEGIC SOURCING SERVICES LLC	70677-1018
Loratadine and Pseudoephedrine	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Extended releaseOral	Ohm Laboratories Inc.	51660-491
Loratadine and Pseudoephedrine Sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Film coated, Extended releaseOral	Strategic Sourcing Services LLC	62011-0071
Loratadine and Pseudoephedrine Sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Film coated, Extended releaseOral	Strategic Sourcing Services LLC	62011-0071
Loratadine and Pseudoephedrine	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	63187-305
Loratadine and Pseudoephedrineloratadine and pseudoephedrine sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Extended releaseOral	Rite Aid	11822-9990
Loratadine and Pseudoephedrine	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Extended releaseOral	Ohm Laboratories Inc.	51660-724
Loratadine and Pseudoephedrine Sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Film coated, Extended releaseOral	HEB	37808-724
Loratadine and Pseudoephedrine	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Extended releaseOral	Sportpharm LLC	85766-048
Allergy Relief-Dloratadine and pseudoephedrine	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Film coated, Extended releaseOral	CVS Pharmacy	59779-726
Leader Allergy Relief D-24loratadine and pseudoephedrine sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Film coated, Extended releaseOral	Cardinal Health	70000-0162
Loratadine and Pseudoephedrine Sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Film coated, Extended releaseOral	Amerisource Bergen	46122-167
Loratadine and Pseudoephedrine Sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Film coated, Extended releaseOral	Meijer Distribution, Inc.	41250-724
Loratadine and Pseudoephedrine Sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Film coated, Extended releaseOral	The Kroger Company	30142-724
Loratadine and Pseudoephedrine Sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Extended releaseOral	WAL-MART STORES, INC	49035-488

Showing 20 of 22.

KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release (Loratadine and pseudoephedrine sulfate) NDC 63981-724