Prescription drug · UNAPPROVED DRUG OTHER
Lextol (Diclofenac sodium, capsaicin) NDC 59088-801
Kit · PureTek Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59088-801-00 | 5908808010059088080100 | 1 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
N459088080100followed by a unit qualifier and the quantityPackage 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.
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.