What is NDC 85477-316?

85477-316 is the product NDC for Hydralyn, Hydrocortisone 2 g/100g gel, listed with the FDA by Oncora Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Oncora Pharma, LLC, NDC labeler code 85477. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hydralyn?

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.

Hydralyn NDC 85477-316 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85477-316Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85477-0316Add 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	Copy
85477-316-28	8547703162885477031628	28 g in 1 TUBE (85477-316-28)Marketed from Jul 28, 2025

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): Hydralyn
Generic name (nonproprietary): hydralyn
Active ingredients: Hydrocortisone — 2 g/100g
Dosage form: Gel
Route: Topical
Labeler: Oncora Pharma, LLCNDC labeler code 85477
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Jul 28, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 85477-316_01324071-1cc1-4031-bdd1-f93eb28e678aSPL ID 01324071-1cc1-4031-bdd1-f93eb28e678aSPL set ID 835f0335-0215-4955-9099-b60160491695RxCUI 604449UNII WI4X0X7BPJUPC 0854770316287
Pharmacologic class: Corticosteroid

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

N485477031628 followed by a unit qualifier and the quantity

Package 85477-0316-28. 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 Aug 12, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85477-316

What is NDC 85477-316?: 85477-316 is the product NDC for Hydralyn, Hydrocortisone 2 g/100g gel, listed with the FDA by Oncora Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hydralyn.
What is the active ingredient?: Hydrocortisone.
Who is the labeler?: Oncora Pharma, LLC, NDC labeler code 85477. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydralyn?: 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.