NDC codes

FDA NDC Directory
Product NDC (as listed)0003-0895Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00003-0895Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0003-0895-11000030895110000308951130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11)Marketed from Sep 9, 2022
0003-0895-91000030895910000308959130 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

N400003089511 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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