NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8713Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8713Add 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 NDC11-digit (billing)PackageCopy
68788-8713-16878887130168788871301100 TABLET in 1 BOTTLE (68788-8713-1)Marketed from Jul 11, 2024
68788-8713-36878887130368788871303330 TABLET in 1 BOTTLE (68788-8713-3)Marketed from Jul 11, 2024
68788-8713-9687888713096878887130990 TABLET in 1 BOTTLE (68788-8713-9)Marketed from Jul 11, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214443
Marketing start
Listing expires
Other FDA classes
Xanthine Oxidase Inhibitors (Mechanism)
Identifiers
Product ID 68788-8713_b114ca0b-b256-4353-be5a-1a4728fbc090SPL ID b114ca0b-b256-4353-be5a-1a4728fbc090SPL set ID 92d9a9d1-76c0-4435-984d-48f44b452855RxCUI 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

N468788871301 followed by a unit qualifier and the quantity

Package 68788-8713-01. 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 .

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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8713

What is NDC 68788-8713?
68788-8713 is the product NDC for Allopurinol, Allopurinol 300 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AllopurinolAllopurinol 100 mg/1TabletOralAvPAK50268-03050268-0030-10
AllopurinolAllopurinol 300 mg/1TabletOralAvPAK50268-03150268-0031-10
AllopurinolAllopurinol 300 mg/1TabletOralCardinal Health 107, LLC55154-028255154-0282-00
AllopurinolAllopurinol 300 mg/1TabletOralREMEDYREPACK INC.70518-469370518-4693-00
AllopurinolAllopurinol 300 mg/1TabletOralSafecor Health, LLC48433-00348433-0003-20
AllopurinolAllopurinol 100 mg/1TabletOralSafecor Health, LLC48433-00248433-0002-20
AllopurinolAllopurinol 300 mg/1TabletOralCoupler LLC67046-165867046-1658-03
AllopurinolAllopurinol 300 mg/1TabletOralREMEDYREPACK INC.70518-455670518-4556-00
AllopurinolAllopurinol 300 mg/1TabletOralNorthwind Health Company, LLC82868-09982868-0099-3082868-0099-90
AllopurinolAllopurinol 100 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC53401-01953401-0019-6053401-0019-80

All 173 Allopurinol NDCs

Other NDCs under ANDA 214443

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

FDA NDC Directory listings under ANDA 214443
ProductStrengthForm · routeLabelerProduct NDC
AllopurinolAllopurinol 100 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-710
AllopurinolAllopurinol 300 mg/1TabletOralCoupler LLC67046-1639
AllopurinolAllopurinol 300 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3672
AllopurinolAllopurinol 100 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3803
AllopurinolAllopurinol 100 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8727
AllopurinolAllopurinol 100 mg/1TabletOralLeading Pharma, LLC69315-291
AllopurinolAllopurinol 300 mg/1TabletOralLeading Pharma, LLC69315-292
AllopurinolAllopurinol 200 mg/1TabletOralLeading Pharma, LLC69315-409
AllopurinolAllopurinol 100 mg/1TabletOralBryant Ranch Prepack71335-2542
AllopurinolAllopurinol 100 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-949
AllopurinolAllopurinol 100 mg/1TabletOralHarman Finochem Limited82638-112
AllopurinolAllopurinol 300 mg/1TabletOralHarman Finochem Limited82638-113

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