Prescription drug · BLA
Keytruda (Pembrolizumab) NDC 0006-3026
Pembrolizumab 25 mg/mL · Injection, Solution · Intravenous · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-3026-02 | 0000630260200006302602 | 1 VIAL in 1 CARTON (0006-3026-02) / 4 mL in 1 VIAL (0006-3026-01)Marketed from Jan 15, 2015 | |
| 0006-3026-04 | 0000630260400006302604 | 2 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
- Pharmacologic class
- Programmed Death Receptor-1 Blocking Antibody
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.
- NDC on a medical claim
N400006302602followed by a unit qualifier and the quantityPackage 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.
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.