Prescription drug · ANDA
Mercaptopurine NDC 0054-4582
Mercaptopurine 20 mg/mL · Suspension · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-4582-49 | 00054458249 | 1 BOTTLE, GLASS in 1 CARTON (0054-4582-49) / 100 mL in 1 BOTTLE, GLASSMarketed from Feb 26, 2025 |
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)
- Mercaptopurine
- Generic name (nonproprietary)
- mercaptopurine
- Active ingredients
- Mercaptopurine — 20 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216418
- Marketing start
- Marketing end
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 0054-4582_7b9eba74-503d-4704-94e9-d52e8701c7bcSPL ID 7b9eba74-503d-4704-94e9-d52e8701c7bcSPL set ID 25b39be7-fe1e-efe6-e063-6294a90a6e8dRxCUI 1536484UNII E7WED276I5
- Pharmacologic class
- Nucleoside Metabolic 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
N400054458249followed by a unit qualifier and the quantityPackage 00054-4582-49. 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)
Mercaptopurine is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia Mercaptopurine is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216418
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 |
|---|---|---|---|---|
| Mercaptopurine | Mercaptopurine 20 mg/mL | SuspensionOral | Hikma Pharmaceuticals USA Inc. | 0054-0879 |