What is NDC 67544-313?

67544-313 is the product NDC for Allopurinol, Allopurinol 300 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 67544. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Allopurinol?

171 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Allopurinol NDC 67544-313 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67544-313Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67544-0313Add 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
67544-313-45	6754403134567544031345	45 TABLET in 1 BOTTLE, PLASTIC (67544-313-45)Marketed from Dec 21, 2022
67544-313-60	6754403136067544031360	90 TABLET in 1 BOTTLE, PLASTIC (67544-313-60)Marketed from Dec 21, 2022

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): Allopurinol
Generic name (nonproprietary): allopurinol
Active ingredients: Allopurinol — 300 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 67544
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 018877
Marketing start: Apr 6, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Xanthine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 67544-313_c5d95534-5585-40ff-9d6c-8b4a62c1b101SPL ID c5d95534-5585-40ff-9d6c-8b4a62c1b101SPL set ID 9b0e3f11-c02a-443d-806f-134c907ea371RxCUI 197320UNII 63CZ7GJN5I
Pharmacologic class: Xanthine Oxidase Inhibitor

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

N467544031345 followed by a unit qualifier and the quantity

Package 67544-0313-45. 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 21, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS ). Allopurinol is indicated in: the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes ele…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67544-313

What is NDC 67544-313?: 67544-313 is the product NDC for Allopurinol, Allopurinol 300 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Allopurinol.
What is the active ingredient?: Allopurinol.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 67544. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Allopurinol?: 171 other product NDCs are listed under this name. See all Allopurinol 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 Allopurinol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Allopurinol	Allopurinol 100 mg/1	TabletOral	AvPAK	50268-030	50268-0030-10
Allopurinol	Allopurinol 300 mg/1	TabletOral	AvPAK	50268-031	50268-0031-10
Allopurinol	Allopurinol 300 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0282	55154-0282-00
Allopurinol	Allopurinol 300 mg/1	TabletOral	REMEDYREPACK INC.	70518-4693	70518-4693-00
Allopurinol	Allopurinol 100 mg/1	TabletOral	Safecor Health, LLC	48433-002	48433-0002-20
Allopurinol	Allopurinol 300 mg/1	TabletOral	Safecor Health, LLC	48433-003	48433-0003-20
Allopurinol	Allopurinol 300 mg/1	TabletOral	Coupler LLC	67046-1658	67046-1658-03
Allopurinol	Allopurinol 300 mg/1	TabletOral	REMEDYREPACK INC.	70518-4556	70518-4556-00
Allopurinol	Allopurinol 300 mg/1	TabletOral	Northwind Health Company, LLC	82868-099	82868-0099-3082868-0099-90
Allopurinol	Allopurinol 100 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	53401-019	53401-0019-6053401-0019-80

All 172 Allopurinol NDCs

Other NDCs under NDA 018877

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

FDA NDC Directory listings under NDA 018877
Product	Strength	Form · route	Labeler	Product NDC
Allopurinol	Allopurinol 300 mg/1	TabletOral	Actavis Pharma, Inc.	0591-5544
Allopurinol	Allopurinol 300 mg/1	TabletOral	Proficient Rx LP	63187-240
Allopurinol	Allopurinol 300 mg/1	TabletOral	Bryant Ranch Prepack	63629-1781