What is NDC 0006-3025?

0006-3025 is the product NDC for Zinplava (bezlotoxumab), Bezlotoxumab 25 mg/mL injection, solution, listed with the FDA by Merck Sharp & Dohme LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zinplava?

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.

Zinplava NDC 0006-3025 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0006-3025Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00006-3025Add 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
0006-3025-00	00006302500	1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3025-00) / 40 mL in 1 VIAL, SINGLE-DOSE (0006-3025-01)Marketed from Oct 21, 2016

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): Zinplava
Generic name (nonproprietary): bezlotoxumab
Active ingredients: Bezlotoxumab — 25 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Merck Sharp & Dohme LLCNDC labeler code 0006
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761046
Marketing start: Oct 21, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 0006-3025_12338d29-efb0-4943-b5f5-826350e9ec46SPL ID 12338d29-efb0-4943-b5f5-826350e9ec46SPL set ID 8f479bfe-2bfa-4cc5-9aee-1357364480b0RxCUI 1855052, 1855057UNII 4H5YMK1H2E

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

N400006302500 followed by a unit qualifier and the quantity

Package 00006-3025-00. 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 Nov 12, 2024.

Indications (excerpt from the label)

ZINPLAVA™ is indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence. ZINPLAVA is a human monoclonal antibody that binds to Clostridioides difficile toxin B, indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence. ( 1 ) Limitation of Use: ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0006-3025

What is NDC 0006-3025?: 0006-3025 is the product NDC for Zinplava (bezlotoxumab), Bezlotoxumab 25 mg/mL injection, solution, listed with the FDA by Merck Sharp & Dohme LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zinplava (Bezlotoxumab).
What is the active ingredient?: Bezlotoxumab.
Who is the labeler?: Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zinplava?: 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.

Zinplava (Bezlotoxumab) NDC 0006-3025