Prescription drug · ANDA
Allopurinol NDC 65219-380
Allopurinol sodium 500 mg/25mL · Injection, Powder, Lyophilized, For solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-380-30 | 6521903803065219038030 | 1 VIAL, GLASS in 1 CARTON (65219-380-30) / 25 mL in 1 VIAL, GLASSMarketed from Mar 14, 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 sodium — 500 mg/25mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212363
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 65219-380_2d2f4a09-b8bd-47ff-87db-a615efc34c4cSPL ID 2d2f4a09-b8bd-47ff-87db-a615efc34c4cSPL set ID 2caf5eed-2408-4ce0-bd0d-04f4c90e434dRxCUI 252931UNII 428673RC2Z
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N465219038030followed by a unit qualifier and the quantityPackage 65219-0380-30. 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 .
Indications (excerpt from the label)
Allopurinol for injection is indicated for 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 and who cannot tolerate oral therapy. Allopurinol for injection is a xanthine oxidase inhibitor indicated for 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 and who cannot tolerate oral therapy. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 65219-380
- What is NDC 65219-380?
- 65219-380 is the product NDC for Allopurinol, Allopurinol sodium 500 mg/25mL injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. 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 sodium.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. 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.
Related NDCs: other Allopurinol products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 212363
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 sodium 500 mg/25mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-380 |