Prescription drug · NDA
Cibinqo (Abrocitinib) NDC 63539-236
Abrocitinib 50 mg/1 · Tablet, Film coated · Oral · U.S. Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63539-236-14 | 6353902361463539023614 | 14 TABLET, FILM COATED in 1 BOTTLE (63539-236-14)Marketed from Feb 24, 2022 · 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)
- Cibinqo
- Generic name (nonproprietary)
- abrocitinib
- Active ingredients
- Abrocitinib — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- U.S. PharmaceuticalsNDC labeler code 63539
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213871
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 63539-236_90d59085-1778-447d-b10a-cede44616558SPL ID 90d59085-1778-447d-b10a-cede44616558SPL set ID 16c12a56-4550-414b-ac9d-b785b41fea6bRxCUI 2591481, 2591487, 2591489, 2591491, 2591493, 2591495UNII 73SM5SF3OR
- Pharmacologic class
- Janus 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
N463539023614followed by a unit qualifier and the quantityPackage 63539-0236-14. 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)
CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Limitations of Use CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants. CIBINQO is a Janus kinase (JAK) inhibitor indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug…
Excerpt only. Read the full label for complete information.
About NDC 63539-236
- What is NDC 63539-236?
- 63539-236 is the product NDC for Cibinqo (abrocitinib), Abrocitinib 50 mg/1 tablet, film coated, listed with the FDA by U.S. Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cibinqo (Abrocitinib).
- What is the active ingredient?
- Abrocitinib.
- Who is the labeler?
- U.S. Pharmaceuticals, NDC labeler code 63539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cibinqo?
- 5 other product NDCs are listed under this name. See all Cibinqo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cibinqo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cibinqoabrocitinib | Abrocitinib 50 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0235 | 00069-0235-30 |
| Cibinqoabrocitinib | Abrocitinib 100 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0335 | 00069-0335-30 |
| Cibinqoabrocitinib | Abrocitinib 200 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0435 | 00069-0435-30 |
| Cibinqoabrocitinib | Abrocitinib 100 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-336 | 63539-0336-14 |
| Cibinqoabrocitinib | Abrocitinib 200 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-436 | 63539-0436-14 |
Other NDCs under NDA 213871
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 |
|---|---|---|---|---|
| Cibinqoabrocitinib | Abrocitinib 50 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0235 |
| Cibinqoabrocitinib | Abrocitinib 100 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0335 |
| Cibinqoabrocitinib | Abrocitinib 200 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0435 |
| Cibinqoabrocitinib | Abrocitinib 100 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-336 |
| Cibinqoabrocitinib | Abrocitinib 200 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-436 |