What is NDC 50881-007?

50881-007 is the product NDC for Opzelura (ruxolitinib), Ruxolitinib phosphate 15 mg/g cream, listed with the FDA by Incyte Corporation. It has 4 package NDCs, shown above in 10- and 11-digit form.

Incyte Corporation, NDC labeler code 50881. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Opzelura?

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.

Opzelura NDC 50881-007 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50881-007Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50881-0007Add 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 NDC	11-digit (billing)	Package
50881-007-04	50881000704	1 TUBE in 1 CARTON (50881-007-04) / 5 g in 1 TUBEMarketed from Sep 21, 2021 · Sample package
50881-007-05	50881000705	1 TUBE in 1 CARTON (50881-007-05) / 60 g in 1 TUBEMarketed from Sep 21, 2021
50881-007-07	50881000707	1 TUBE in 1 CARTON (50881-007-07) / 100 g in 1 TUBEMarketed from Apr 15, 2022
50881-007-14	50881000714	1 TUBE in 1 CARTON (50881-007-14) / 3 g in 1 TUBEMarketed from Nov 10, 2025 · 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): Opzelura
Generic name (nonproprietary): ruxolitinib
Active ingredients: Ruxolitinib phosphate — 15 mg/g
Dosage form: Cream
Route: Topical
Labeler: Incyte CorporationNDC labeler code 50881
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 215309
Marketing start: Sep 21, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 50881-007_af30042b-ecb2-4e8b-82be-117685dff4edSPL ID af30042b-ecb2-4e8b-82be-117685dff4edSPL set ID 24da5509-6631-4795-9d42-273faecd08e7RxCUI 2570752, 2570757UNII 436LRU32H5
Pharmacologic class: Janus Kinase Inhibitor; 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450881000704 followed by a unit qualifier and the quantity

Package 50881-0007-04. 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 Jun 30, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

OPZELURA is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ( 1.1 ) the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. ( 1.2 ) Limitations of Use Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended. ( 1.3 ) 1.1 Atopic Dermatitis OPZELU…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50881-007

What is NDC 50881-007?: 50881-007 is the product NDC for Opzelura (ruxolitinib), Ruxolitinib phosphate 15 mg/g cream, listed with the FDA by Incyte Corporation. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Opzelura (Ruxolitinib).
What is the active ingredient?: Ruxolitinib phosphate.
Who is the labeler?: Incyte Corporation, NDC labeler code 50881. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Opzelura?: 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.

Opzelura (Ruxolitinib) NDC 50881-007