NDC codes

FDA NDC Directory
Product NDC (as listed)0006-3026Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00006-3026Add 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 NDC11-digit (billing)PackageCopy
0006-3026-0200006302602000063026021 VIAL in 1 CARTON (0006-3026-02) / 4 mL in 1 VIAL (0006-3026-01)Marketed from Jan 15, 2015
0006-3026-0400006302604000063026042 VIAL in 1 CARTON (0006-3026-04) / 4 mL in 1 VIAL (0006-3026-01)Marketed from Aug 1, 2019

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)
Keytruda
Generic name (nonproprietary)
pembrolizumab
Active ingredients
Pembrolizumab — 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 125514
Marketing start
Listing expires
Other FDA classes
Programmed Death Receptor-1-directed Antibody Interactions (Mechanism)
Identifiers
Product ID 0006-3026_228e1e3f-d207-481f-8e14-9fdcbd0470e9SPL ID 228e1e3f-d207-481f-8e14-9fdcbd0470e9SPL set ID 9333c79b-d487-4538-a9f0-71b91a02b287RxCUI 1657746, 1657749, 1657750, 1657751UNII DPT0O3T46P

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 codeMed-Code curated

J9271 — Injection, pembrolizumab, 1 mg

Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.

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

N400006302602 followed by a unit qualifier and the quantity

Package 00006-3026-02. 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)

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC. ( 1.2 ) …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0006-3026

What is NDC 0006-3026?
0006-3026 is the product NDC for Keytruda (pembrolizumab), Pembrolizumab 25 mg/mL injection, solution, listed with the FDA by Merck Sharp & Dohme LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Keytruda (Pembrolizumab).
What is the active ingredient?
Pembrolizumab.
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 Keytruda?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Yes: J9271, Injection, pembrolizumab, 1 mg. See Billing references above.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in