Prescription drug · NDA
Venclexta (Venetoclax) NDC 0074-0566
Venetoclax 50 mg/1 · Tablet, Film coated · Oral · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-0566-07 | 00074056607 | 1 BLISTER PACK in 1 CARTON (0074-0566-07) / 7 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 11, 2016 | |
| 0074-0566-11 | 00074056611 | 1 BLISTER PACK in 1 CARTON (0074-0566-11) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 11, 2016 |
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)
- Venclexta
- Generic name (nonproprietary)
- venetoclax
- Active ingredients
- Venetoclax — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208573
- Marketing start
- Listing expires
- Other FDA classes
- Increased Cellular Death (Physiologic effect)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0074-0566_5d893369-497c-46ee-9b64-ee737fab4225SPL ID 5d893369-497c-46ee-9b64-ee737fab4225SPL set ID b118a40d-6b56-cee3-10f6-ded821a97018RxCUI 1747561, 1747567, 1747572, 1747574, 1747575, 1747577, 1747579, 1747580UNII N54AIC43PW
- Pharmacologic class
- BCL-2 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
N400074056607followed by a unit qualifier and the quantityPackage 00074-0566-07. 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)
VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.1 ) In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 1.2 Acute Myeloid Leukemia VENCLEXTA is indicated in combination with azacitidine, or …
Excerpt only. Read the full label for complete information.
About NDC 0074-0566
- What is NDC 0074-0566?
- 0074-0566 is the product NDC for Venclexta (venetoclax), Venetoclax 50 mg/1 tablet, film coated, listed with the FDA by AbbVie Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Venclexta (Venetoclax).
- What is the active ingredient?
- Venetoclax.
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Venclexta?
- 3 other product NDCs are listed under this name. See all Venclexta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Venclexta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Venclextavenetoclax | — | Kit | AbbVie Inc. | 0074-0579 | 00074-0579-28 |
| Venclextavenetoclax | Venetoclax 100 mg/1 | Tablet, Film coatedOral | AbbVie Inc. | 0074-0576 | 00074-0576-1100074-0576-2200074-0576-30 |
| Venclextavenetoclax | Venetoclax 10 mg/1 | Tablet, Film coatedOral | AbbVie Inc. | 0074-0561 | 00074-0561-1100074-0561-14 |
Other NDCs under NDA 208573
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 |
|---|---|---|---|---|
| Venclextavenetoclax | — | Kit | AbbVie Inc. | 0074-0579 |
| Venclextavenetoclax | Venetoclax 100 mg/1 | Tablet, Film coatedOral | AbbVie Inc. | 0074-0576 |
| Venclextavenetoclax | Venetoclax 10 mg/1 | Tablet, Film coatedOral | AbbVie Inc. | 0074-0561 |