NDC codes

FDA NDC Directory
Product NDC (as listed)50242-917Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50242-0917Add 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
50242-917-0150242091701502420917011 VIAL, SINGLE-USE in 1 CARTON (50242-917-01) / 20 mL in 1 VIAL, SINGLE-USEMarketed from May 18, 2016
50242-917-8650242091786502420917861 VIAL, SINGLE-USE in 1 CARTON (50242-917-86) / 20 mL in 1 VIAL, SINGLE-USEMarketed from Aug 11, 2016 · Sample package

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Tecentriq
Generic name (nonproprietary)
atezolizumab
Active ingredients
Atezolizumab — 1200 mg/20mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Genentech, Inc.NDC labeler code 50242
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 761034
Marketing start
Listing expires
Other FDA classes
Antibodies (Chemical structure)Monoclonal (Chemical structure)Humanized (Chemical structure)Programmed Death Receptor-1-directed Antibody Interactions (Mechanism)
Identifiers
Product ID 50242-917_4b922b35-c401-4189-a8b2-9f9a820878dbSPL ID 4b922b35-c401-4189-a8b2-9f9a820878dbSPL set ID 6fa682c9-a312-4932-9831-f286908660eeRxCUI 1792780, 1792785, 2119695, 2119696UNII 52CMI0WC3Y

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

J9022 — Injection, atezolizumab, 10 mg

Billing unit: 10 mg. Units on the claim = dose given ÷ 10 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

N450242091701 followed by a unit qualifier and the quantity

Package 50242-0917-01. 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 .

Indications (excerpt from the label)

TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test. ( 1.1 , 14.1 ) for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations. ( 1.1 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50242-917

What is NDC 50242-917?
50242-917 is the product NDC for Tecentriq (atezolizumab), Atezolizumab 1200 mg/20mL injection, solution, listed with the FDA by Genentech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tecentriq (Atezolizumab).
What is the active ingredient?
Atezolizumab.
Who is the labeler?
Genentech, Inc., NDC labeler code 50242. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tecentriq?
1 other product NDC are listed under this name. See all Tecentriq NDCs.
Is there a related HCPCS / J-code?
Yes: J9022, Injection, atezolizumab, 10 mg. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tecentriq NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TecentriqatezolizumabAtezolizumab 840 mg/14mLInjection, SolutionIntravenousGenentech, Inc.50242-91850242-0918-01

Other NDCs under BLA 761034

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761034
ProductStrengthForm · routeLabelerProduct NDC
TecentriqatezolizumabAtezolizumab 840 mg/14mLInjection, SolutionIntravenousGenentech, Inc.50242-918

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