What is NDC 0008-4510?

0008-4510 is the product NDC for Mylotarg (gemtuzumab ozogamicin), Gemtuzumab ozogamicin 5 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Mylotarg (Gemtuzumab ozogamicin).

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., NDC labeler code 0008. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Mylotarg?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mylotarg NDC 0008-4510 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0008-4510Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00008-4510Add 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
0008-4510-01	00008451001	1 VIAL, SINGLE-DOSE in 1 CARTON (0008-4510-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 7, 2017

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): Mylotarg
Generic name (nonproprietary): gemtuzumab ozogamicin
Active ingredients: Gemtuzumab ozogamicin — 5 mg/5mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDC labeler code 0008
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761060
Marketing start: Sep 7, 2017
Listing expires: Dec 31, 2026
Other FDA classes: CD33-directed Antibody Interactions (Mechanism)
Identifiers: Product ID 0008-4510_ef242018-af2a-4c03-99b7-908e2610f86fSPL ID ef242018-af2a-4c03-99b7-908e2610f86fSPL set ID 32fd2bb2-1cfa-4250-feb8-d7956c794e05RxCUI 1944701, 1944704UNII 8GZG754X6M
Pharmacologic class: CD33-directed Immunoconjugate

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.

How CPT relates to drug billing

NDC on a medical claim

N400008451001 followed by a unit qualifier and the quantity

Package 00008-4510-01. 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 Dec 19, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ). • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older ( 1.2 ). 1.1 Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML) MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older. 1.2 Relapsed or Refractory CD33-positive AML MYLOTARG is indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0008-4510

What is NDC 0008-4510?: 0008-4510 is the product NDC for Mylotarg (gemtuzumab ozogamicin), Gemtuzumab ozogamicin 5 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Mylotarg (Gemtuzumab ozogamicin).
What is the active ingredient?: Gemtuzumab ozogamicin.
Who is the labeler?: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., NDC labeler code 0008. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mylotarg?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Mylotarg (Gemtuzumab ozogamicin) NDC 0008-4510