What is NDC 71610-194?

71610-194 is the product NDC for Allopurinol, Allopurinol 100 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 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 71610-194 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-194Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0194Add 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
71610-194-30	7161001943071610019430	30 TABLET in 1 BOTTLE (71610-194-30)Marketed from Jun 9, 2021
71610-194-60	7161001946071610019460	90 TABLET in 1 BOTTLE (71610-194-60)Marketed from Nov 16, 2018
71610-194-80	7161001948071610019480	180 TABLET in 1 BOTTLE (71610-194-80)Marketed from Jan 8, 2019

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 — 100 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 071586
Marketing start: Oct 1, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Xanthine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 71610-194_f91cc234-c1d7-4d08-bfca-4966770a3339SPL ID f91cc234-c1d7-4d08-bfca-4966770a3339SPL set ID 3dc4980c-8062-4239-a860-63888cabee46RxCUI 197319UNII 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

N471610019430 followed by a unit qualifier and the quantity

Package 71610-0194-30. 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 3, 2021.

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 elevat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-194

What is NDC 71610-194?: 71610-194 is the product NDC for Allopurinol, Allopurinol 100 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 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 071586

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

FDA NDC Directory listings under ANDA 071586
Product	Strength	Form · route	Labeler	Product NDC
Allopurinol	Allopurinol 100 mg/1	TabletOral	Northwind Health Company, LLC	51655-546
Allopurinol	Allopurinol 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-1656