What is NDC 0054-4581?

0054-4581 is the product NDC for Mercaptopurine, Mercaptopurine 50 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Mercaptopurine?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mercaptopurine NDC 0054-4581 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-4581Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-4581Add 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
0054-4581-11	0005445811100054458111	25 TABLET in 1 BOTTLE, PLASTIC (0054-4581-11)Marketed from Feb 13, 2004
0054-4581-27	0005445812700054458127	250 TABLET in 1 BOTTLE, PLASTIC (0054-4581-27)Marketed from Feb 13, 2004

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 — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040528
Marketing start: Feb 13, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 0054-4581_564261a6-c6b6-4d31-bf80-36fe086e73e8SPL ID 564261a6-c6b6-4d31-bf80-36fe086e73e8SPL set ID c3b5b8b0-bc5c-4ce9-bbdc-febba60c2658RxCUI 197931UNII E7WED276I5UPC 0300544581271, 0300544581110
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

N400054458111 followed by a unit qualifier and the quantity

Package 00054-4581-11. 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 Oct 1, 2024.

Indications (excerpt from the label)

Mercaptopurine Tablets is a nucleoside metabolic inhibitor indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. (1.1) 1.1 Acute Lymphoblastic Leukemia Mercaptopurine Tablets are indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-4581

What is NDC 0054-4581?: 0054-4581 is the product NDC for Mercaptopurine, Mercaptopurine 50 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Mercaptopurine.
What is the active ingredient?: Mercaptopurine.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mercaptopurine?: 5 other product NDCs are listed under this name. See all Mercaptopurine 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 Mercaptopurine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Mercaptopurine	Mercaptopurine 50 mg/1	TabletOral	Florida Pharmaceutical Products, LLC	71921-150	71921-0150-0271921-0150-25
Mercaptopurine	Mercaptopurine 20 mg/mL	SuspensionOral	Nova Laboratories, Ltd	62484-1020	62484-1020-04
Mercaptopurine	Mercaptopurine 20 mg/mL	SuspensionOral	Hikma Pharmaceuticals USA Inc.	0054-0879	00054-0879-49
Mercaptopurine	Mercaptopurine 20 mg/mL	SuspensionOral	Hikma Pharmaceuticals USA Inc.	0054-4582	00054-4582-49
Mercaptopurine	Mercaptopurine 50 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-983	51407-0983-25

Other NDCs under ANDA 040528

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

FDA NDC Directory listings under ANDA 040528
Product	Strength	Form · route	Labeler	Product NDC
Mercaptopurine	Mercaptopurine 50 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-983