Prescription drug · ANDA
Allopurinol NDC 0603-2116
Allopurinol 300 mg/1 · Tablet · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0603-2116-21 | 00603211621 | 100 TABLET in 1 BOTTLE, PLASTIC (0603-2116-21)Marketed from Jun 27, 2003 | |
| 0603-2116-28 | 00603211628 | 500 TABLET in 1 BOTTLE, PLASTIC (0603-2116-28)Marketed from Jun 27, 2003 | |
| 0603-2116-32 | 00603211632 | 1000 TABLET in 1 BOTTLE, PLASTIC (0603-2116-32)Marketed from Jun 27, 2003 |
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 — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075798
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 0603-2116_14909994-d957-4d81-a6e6-68d64107fd1bSPL ID 14909994-d957-4d81-a6e6-68d64107fd1bSPL set ID fbac3b4f-dc23-4359-ac3f-2b3fdde41af2RxCUI 197319, 197320UNII 63CZ7GJN5IUPC 0306032115218, 0306032116215
- 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
N400603211621followed by a unit qualifier and the quantityPackage 00603-2116-21. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 075798
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7981 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6572 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4286 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8517 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Par Health USA, LLC | 0603-2115 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1149 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1150 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8385 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2111 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2112 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2113 |