What is NDC 71610-681?

71610-681 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 71610. 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?

172 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 71610-681 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-681Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0681Add 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
71610-681-45	7161006814571610068145	45 TABLET in 1 BOTTLE (71610-681-45)Marketed from Dec 13, 2022
71610-681-60	7161006816071610068160	90 TABLET in 1 BOTTLE (71610-681-60)Marketed from Dec 13, 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 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204467
Marketing start: Mar 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Xanthine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 71610-681_fe21f4f9-59eb-4885-90b5-c2859a714516SPL ID fe21f4f9-59eb-4885-90b5-c2859a714516SPL set ID a5c35283-09d2-4bb4-bdd1-055035fa272bRxCUI 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

N471610068145 followed by a unit qualifier and the quantity

Package 71610-0681-45. 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 13, 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 tablets reduce 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 tablets are indicated in: 1. the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). 2. the management of patients with leukemia, lymphoma and malignancies who are receiving cancer th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-681

What is NDC 71610-681?: 71610-681 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 71610. 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?: 172 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 300 mg/1	TabletOral	Safecor Health, LLC	48433-003	48433-0003-20
Allopurinol	Allopurinol 100 mg/1	TabletOral	Safecor Health, LLC	48433-002	48433-0002-20
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 173 Allopurinol NDCs

Other NDCs under ANDA 204467

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

FDA NDC Directory listings under ANDA 204467
Product	Strength	Form · route	Labeler	Product NDC
Allopurinol	Allopurinol 300 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3605
Allopurinol	Allopurinol 300 mg/1	TabletOral	Indoco Remedies Limited	14445-171
Allopurinol	Allopurinol 100 mg/1	TabletOral	Indoco Remedies Limited	14445-170
Allopurinol	Allopurinol 200 mg/1	TabletOral	Indoco Remedies Limited	14445-172
Allopurinol	Allopurinol 100 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-676
Allopurinol	Allopurinol 300 mg/1	TabletOral	Florida Pharmaceutical Products, LLC	71921-242
Allopurinol	Allopurinol 100 mg/1	TabletOral	Florida Pharmaceutical Products, LLC	71921-240
Allopurinol	Allopurinol 200 mg/1	TabletOral	Florida Pharmaceutical Products, LLC	71921-241
Allopurinol	Allopurinol 100 mg/1	TabletOral	Northwind Health Company, LLC	51655-945
Allopurinol	Allopurinol 300 mg/1	TabletOral	REMEDYREPACK INC.	70518-4693
Allopurinol	Allopurinol 100 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3871
Allopurinol	Allopurinol 300 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-722
Allopurinol	Allopurinol 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-2347
Allopurinol	Allopurinol 100 mg/1	TabletOral	AvPAK	50268-030
Allopurinol	Allopurinol 300 mg/1	TabletOral	AvPAK	50268-031
Allopurinol	Allopurinol 300 mg/1	TabletOral	A-S Medication Solutions	50090-6882
Allopurinol	Allopurinol 300 mg/1	TabletOral	NorthStar RxLLC	16714-577
Allopurinol	Allopurinol 300 mg/1	TabletOral	Direct_Rx	72189-417
Allopurinol	Allopurinol 100 mg/1	TabletOral	NorthStar RxLLC	16714-576
Allopurinol	Allopurinol 300 mg/1	TabletOral	REMEDYREPACK INC.	70518-4556

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