Prescription drug · NDA
Verzenio (abemaciclib) NDC 0002-4483
Abemaciclib 50 mg/1 · Tablet · Oral · Eli Lilly and Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0002-4483-54 | 00002448354 | 1 BLISTER PACK in 1 CARTON (0002-4483-54) / 14 TABLET in 1 BLISTER PACKMarketed from Oct 6, 2017 | |
| 0002-4483-62 | 00002448362 | 2 BLISTER PACK in 1 CARTON (0002-4483-62) / 14 TABLET in 1 BLISTER PACKMarketed from Feb 15, 2025 · Sample package |
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)
- Verzenio
- Generic name (nonproprietary)
- abemaciclib
- Active ingredients
- Abemaciclib — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Eli Lilly and Company
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208716
- Marketing start
- Listing expires
- Other FDA classes
- Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0002-4483_5b2d0f4e-5bba-4048-a2f0-bcb4b779efc0SPL ID 5b2d0f4e-5bba-4048-a2f0-bcb4b779efc0SPL set ID be4bc0de-0fdc-4d46-8d25-be43c79e6a06RxCUI 1946830, 1946836, 1946838, 1946840, 1946842, 1946844, 1946846, 1946848UNII 60UAB198HK
- Pharmacologic class
- Kinase Inhibitor
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400002448354followed by a unit qualifier and the quantityPackage 00002-4483-54. 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)
VERZENIO ® is a kinase inhibitor indicated: in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. ( 1.1 , 14.1 ) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. ( 1.2 ) in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, hum…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208716
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 |
|---|---|---|---|---|
| Verzenioabemaciclib | Abemaciclib 200 mg/1 | TabletOral | Eli Lilly and Company | 0002-6216 |
| Verzenioabemaciclib | Abemaciclib 100 mg/1 | TabletOral | Eli Lilly and Company | 0002-4815 |
| Verzenioabemaciclib | Abemaciclib 150 mg/1 | TabletOral | Eli Lilly and Company | 0002-5337 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.