What is NDC 0591-5543?

0591-5543 is the product NDC for Allopurinol, Allopurinol 100 mg/1 tablet, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0591. 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?

167 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 0591-5543 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-5543Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-5543Add 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
0591-5543-10	00591554310	1000 TABLET in 1 BOTTLE, PLASTIC (0591-5543-10)Marketed from Apr 6, 2009

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Actavis Pharma, Inc.NDC labeler code 0591
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 018832
Marketing start: Apr 6, 2009
Marketing end: Apr 30, 2027
Other FDA classes: Xanthine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 0591-5543_f7e04d88-1d9b-47e6-a9ad-deb08af3c098SPL ID f7e04d88-1d9b-47e6-a9ad-deb08af3c098SPL set ID a80fe56f-8d03-423f-8e2a-7ec8c9e5045bRxCUI 197319, 197320UNII 63CZ7GJN5IUPC 0305915544015, 0305915543018
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

N400591554310 followed by a unit qualifier and the quantity

Package 00591-5543-10. 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 Apr 1, 2024.

Indications (excerpt from the label)

Allopurinol Tablets are indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0591-5543

What is NDC 0591-5543?: 0591-5543 is the product NDC for Allopurinol, Allopurinol 100 mg/1 tablet, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, 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?: Actavis Pharma, Inc., NDC labeler code 0591. 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?: 167 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 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
Allopurinol	Allopurinol 300 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	53401-025	53401-0025-60
Allopurinol	Allopurinol 100 mg/1	TabletOral	XLCare Pharmaceuticals Inc.	72865-303	72865-0303-0172865-0303-0572865-0303-10+1 more

All 168 Allopurinol NDCs

Other NDCs under NDA 018832

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

FDA NDC Directory listings under NDA 018832
Product	Strength	Form · route	Labeler	Product NDC
Allopurinol	Allopurinol 100 mg/1	TabletOral	Proficient Rx LP	63187-463