Over-the-counter drug · ANDA
Topcare lice killing creme rinse (Permethrin) NDC 36800-629
Permethrin 1 mg/100mL · Lotion · Topical · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-629-26 | 36800062926 | 2 BOTTLE in 1 CARTON (36800-629-26) / 59 mL in 1 BOTTLEMarketed from Jan 31, 2020 |
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)
- Topcare lice killing creme rinse
- Generic name (nonproprietary)
- permethrin
- Active ingredients
- Permethrin — 1 mg/100mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076090
- Marketing start
- Listing expires
- Other FDA classes
- Pyrethrins (Chemical structure)
- Identifiers
- Product ID 36800-629_ed4f8790-6cfe-4de9-9193-401908cbdd4dSPL ID ed4f8790-6cfe-4de9-9193-401908cbdd4dSPL set ID 3b4146a6-7c54-4dd0-9388-1e38491d16f3UNII 509F88P9SZ
- Pharmacologic class
- Pyrethroid
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
N436800062926followed by a unit qualifier and the quantityPackage 36800-0629-26. 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)
Use treats head lice
Excerpt only. Read the full label for complete information.
About NDC 36800-629
- What is NDC 36800-629?
- 36800-629 is the product NDC for Topcare lice killing creme rinse (permethrin), Permethrin 1 mg/100mL lotion, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topcare lice killing creme rinse (Permethrin).
- What is the active ingredient?
- Permethrin.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Topcare lice killing creme rinse?
- 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.
Other NDCs under ANDA 076090
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| good sense lice killing creme rinsepermethrin | Permethrin 1 mg/100mL | LotionTopical | L. Perrigo Company | 0113-1910 |