Prescription drug · BLA
Hemlibra (Emicizumab) NDC 50242-921
Emicizumab 60 mg/.4mL · Injection, Solution · Subcutaneous · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-921-01 | 50242092101 | 1 VIAL, SINGLE-USE in 1 CARTON (50242-921-01) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Nov 16, 2017 |
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)
- Hemlibra
- Generic name (nonproprietary)
- emicizumab
- Active ingredients
- Emicizumab — 60 mg/.4mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761083
- Marketing start
- Listing expires
- Identifiers
- Product ID 50242-921_8f25ff10-e9d1-46a1-9889-e2c3f6e0d432SPL ID 8f25ff10-e9d1-46a1-9889-e2c3f6e0d432SPL set ID 2483adba-fab6-4d1b-96c5-c195577ed071RxCUI 1989799, 1989804, 1989809, 1989811, 1989814, 1989815, 1989816, 1989817, 2632728, 2632729, 2675567, 2675568UNII 7NL2E3F6K3
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.
- NDC on a medical claim
N450242092101followed by a unit qualifier and the quantityPackage 50242-0921-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. HEMLIBRA is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 50242-921
- What is NDC 50242-921?
- 50242-921 is the product NDC for Hemlibra (emicizumab), Emicizumab 60 mg/.4mL injection, solution, listed with the FDA by Genentech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hemlibra (Emicizumab).
- What is the active ingredient?
- Emicizumab.
- 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 Hemlibra?
- 5 other product NDCs are listed under this name. See all Hemlibra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hemlibra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hemlibraemicizumab | Emicizumab 12 mg/.4mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-927 | 50242-0927-01 |
| Hemlibraemicizumab | Emicizumab 300 mg/2mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-930 | 50242-0930-01 |
| Hemlibraemicizumab | Emicizumab 30 mg/mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-920 | 50242-0920-01 |
| Hemlibraemicizumab | Emicizumab 105 mg/.7mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-922 | 50242-0922-01 |
| Hemlibraemicizumab | Emicizumab 150 mg/mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-923 | 50242-0923-01 |
Other NDCs under BLA 761083
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hemlibraemicizumab | Emicizumab 30 mg/mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-920 |
| Hemlibraemicizumab | Emicizumab 105 mg/.7mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-922 |
| Hemlibraemicizumab | Emicizumab 150 mg/mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-923 |
| Hemlibraemicizumab | Emicizumab 12 mg/.4mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-927 |
| Hemlibraemicizumab | Emicizumab 300 mg/2mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-930 |