Prescription drug · NDA
Sotyktu (Deucravacitinib) NDC 0003-0895
Deucravacitinib 6 mg/1 · Tablet, Film coated · Oral · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-0895-11 | 0000308951100003089511 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11)Marketed from Sep 9, 2022 | |
| 0003-0895-91 | 0000308959100003089591 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0003-0895-91)Marketed from Sep 9, 2022 · 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)
- Sotyktu
- Generic name (nonproprietary)
- deucravacitinib
- Active ingredients
- Deucravacitinib — 6 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- E.R. Squibb & Sons, L.L.C.NDC labeler code 0003
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214958
- Marketing start
- Listing expires
- Other FDA classes
- Tyrosine Kinase 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 0003-0895_73204bef-9921-40ed-9230-ba35953c99c4SPL ID 73204bef-9921-40ed-9230-ba35953c99c4SPL set ID ff4d7258-5068-4cdf-9692-8cae04c3198eRxCUI 2612092, 2612098UNII N0A21N6RAU
- Pharmacologic class
- Tyrosine Kinase 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
N400003089511followed by a unit qualifier and the quantityPackage 00003-0895-11. 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)
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for: • the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Limitations of Use : Not recommended for use in combination with other potent immunosuppressants. • the treatment of active psoriatic arthritis in adults. ( 1.2 ) 1.1 Plaque Psoriasis SOTYKTU is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Limitations of Use : SOTYKTU is not recommended for use in combination with other potent immunosuppressants. 1.2 Psoriatic Arthritis SOTYKTU is indicated for the treatment of act…
Excerpt only. Read the full label for complete information.
About NDC 0003-0895
- What is NDC 0003-0895?
- 0003-0895 is the product NDC for Sotyktu (deucravacitinib), Deucravacitinib 6 mg/1 tablet, film coated, listed with the FDA by E.R. Squibb & Sons, L.L.C.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sotyktu (Deucravacitinib).
- What is the active ingredient?
- Deucravacitinib.
- Who is the labeler?
- E.R. Squibb & Sons, L.L.C., NDC labeler code 0003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sotyktu?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.