What is NDC 0008-0100?

0008-0100 is the product NDC for Besponsa (inotuzumab ozogamicin), Inotuzumab ozogamicin .25 mg/mL 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?

Besponsa (Inotuzumab 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 Besponsa?

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.

Besponsa NDC 0008-0100 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0008-0100Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00008-0100Add 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
0008-0100-01	00008010001	1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 18, 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): Besponsa
Generic name (nonproprietary): inotuzumab ozogamicin
Active ingredients: Inotuzumab ozogamicin — .25 mg/mL
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 761040
Marketing start: Aug 18, 2017
Listing expires: Dec 31, 2027
Other FDA classes: CD22-directed Antibody Interactions (Mechanism)Decreased DNA Integrity (Physiologic effect)Immunoconjugates (Chemical structure)Increased Cellular Death (Physiologic effect)
Identifiers: Product ID 0008-0100_427d10d2-c29d-4b71-a5fe-c97736d59aa6SPL ID 427d10d2-c29d-4b71-a5fe-c97736d59aa6SPL set ID cc7014b1-c775-411d-b374-8113248b4077RxCUI 1942954, 1942959UNII P93RUU11P7
Pharmacologic class: CD22-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

N400008010001 followed by a unit qualifier and the quantity

Package 00008-0100-01. 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 Feb 6, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older . BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0008-0100

What is NDC 0008-0100?: 0008-0100 is the product NDC for Besponsa (inotuzumab ozogamicin), Inotuzumab ozogamicin .25 mg/mL 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?: Besponsa (Inotuzumab ozogamicin).
What is the active ingredient?: Inotuzumab 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 Besponsa?: 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.

Besponsa (Inotuzumab ozogamicin) NDC 0008-0100