NDC codes

FDA NDC Directory
Product NDC (as listed)59088-801Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59088-0801Add 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
59088-801-0059088080100590880801001 KIT in 1 KIT (59088-801-00) * 1 BOTTLE, DROPPER in 1 CARTON (59088-435-10) / 150 mL in 1 BOTTLE, DROPPER * 237 mL in 1 BOTTLE, PUMP (59088-310-16)Marketed from Aug 30, 2023

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)
Lextol
Generic name (nonproprietary)
diclofenac sodium, capsaicin
Dosage form
Kit
Labeler
PureTek CorporationNDC labeler code 59088
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 59088-801_4656d7e0-9978-7b5d-e063-6294a90ac20eSPL ID 4656d7e0-9978-7b5d-e063-6294a90ac20eSPL set ID 042765e5-bd75-8224-e063-6394a90a141bRxCUI 198555, 857700

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N459088080100 followed by a unit qualifier and the quantity

Package 59088-0801-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Diclofenac sodium topical solution, USP is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59088-801

What is NDC 59088-801?
59088-801 is the product NDC for Lextol kit, listed with the FDA by PureTek Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Lextol (Diclofenac Sodium, Capsaicin).
Who is the labeler?
PureTek Corporation, NDC labeler code 59088. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lextol?
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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