NDC codes

FDA NDC Directory
Product NDC (as listed)11086-030Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11086-0030Add 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
11086-030-1011086003010100 g in 1 TUBE (11086-030-10)Marketed from Nov 1, 2009
11086-030-601108600306060 g in 1 BOTTLE, WITH APPLICATOR (11086-030-60)Marketed from Nov 1, 2009

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)
Keralyt
Generic name (nonproprietary)
salicylic acid
Active ingredients
Salicylic acid — 6 g/100g
Dosage form
Gel
Route
Topical
Labeler
Summers Laboratories IncNDC labeler code 11086
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 11086-030_521a893e-bafa-ccfa-e063-6294a90a6119SPL ID 521a893e-bafa-ccfa-e063-6294a90a6119SPL set ID 8195e4e0-b812-11de-81b4-0002a5d5c51bRxCUI 212332, 312893UNII O414PZ4LPZ

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

N411086003010 followed by a unit qualifier and the quantity

Package 11086-0030-10. 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)

INDICATIONS AND USAGE - For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11086-030

What is NDC 11086-030?
11086-030 is the product NDC for Keralyt (salicylic acid), Salicylic acid 6 g/100g gel, listed with the FDA by Summers Laboratories Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Keralyt (Salicylic acid).
What is the active ingredient?
Salicylic acid.
Who is the labeler?
Summers Laboratories Inc, NDC labeler code 11086. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Keralyt?
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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