Over-the-counter drug · OTC MONOGRAPH FINAL
Lice Killing (Piperonyl butoxide, pyrethrum extract) NDC 11383-253
Piperonyl butoxide 4 g/100mL; Pyrethrum extract .33 g/100mL · Shampoo · Topical · Weeks & Leo Co., Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11383-253-02 | 11383025302 | 1 BOTTLE in 1 CARTON (11383-253-02) / 59 mL in 1 BOTTLEMarketed from Oct 11, 2012 | |
| 11383-253-04 | 11383025304 | 1 BOTTLE in 1 CARTON (11383-253-04) / 118 mL in 1 BOTTLEMarketed from Oct 11, 2012 | |
| 11383-253-06 | 11383025306 | 1 BOTTLE in 1 CARTON (11383-253-06) / 177 mL in 1 BOTTLEMarketed from Oct 11, 2012 | |
| 11383-253-08 | 11383025308 | 1 BOTTLE in 1 CARTON (11383-253-08) / 237 mL in 1 BOTTLEMarketed from Oct 11, 2017 |
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)
- Lice Killing
- Generic name (nonproprietary)
- piperonyl butoxide, pyrethrum extract
- Active ingredients
- Piperonyl butoxide — 4 g/100mLPyrethrum extract — .33 g/100mL
- Dosage form
- Shampoo
- Route
- Topical
- Labeler
- Weeks & Leo Co., Inc.NDC labeler code 11383
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part358G
- Marketing start
- Listing expires
- Identifiers
- Product ID 11383-253_471758a2-9b34-29e8-e054-00144ff88e88SPL ID 471758a2-9b34-29e8-e054-00144ff88e88SPL set ID c44da21d-7875-48ae-bcbe-6e593e290433RxCUI 283219UNII LWK91TU9AH, ZUM06L90GV
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
N411383025302followed by a unit qualifier and the quantityPackage 11383-0253-02. 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)
Uses treats head, pubic (crab), and body lice
Excerpt only. Read the full label for complete information.
About NDC 11383-253
- What is NDC 11383-253?
- 11383-253 is the product NDC for Lice Killing, Piperonyl butoxide 4 g/100mL; Pyrethrum extract .33 g/100mL shampoo, listed with the FDA by Weeks & Leo Co., Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lice Killing (Piperonyl butoxide, Pyrethrum extract).
- What is the active ingredient?
- Piperonyl butoxide, Pyrethrum extract.
- Who is the labeler?
- Weeks & Leo Co., Inc., NDC labeler code 11383. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lice Killing?
- 2 other product NDCs are listed under this name. See all Lice Killing NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lice Killing products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lice Killingpiperonyl butoxide, pyrethrum extract | Piperonyl butoxide 4 g/100mL; Pyrethrum extract .33 g/100mL | ShampooTopical | Weeks & Leo Co., Inc. | 11383-310 | 11383-0310-02 |
| Lice Killingpiperonyl butoxide, pyrethrum extract | Piperonyl butoxide 4 g/100mL; Pyrethrum extract .33 g/100mL | ShampooTopical | PHARMACY VALUE ALLIANCE LLC | 68016-253 | 68016-0253-04 |
Other NDCs under part358G
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 |
|---|---|---|---|---|
| Herklinpiperonyl butoxide and pyrethrum extract | Piperonyl butoxide 40 mg/mL; Pyrethrum extract .033 mg/mL | ShampooTopical | MarcusUSA | 75940-171 |
| Herklin Lice Treatmentpiperonyl butoxide, pyrethrum extract | Piperonyl butoxide 4 g/100mL; Pyrethrum extract .33 g/100mL | ShampooTopical | MarcasUSA LLC | 75940-192 |
| Best Choice Lice Killingpiperonyl butoxide, pyrethrum extract | Piperonyl butoxide 4 g/100mL; Pyrethrum extract .33 g/100mL | ShampooTopical | Valu Merchandisers, CO. | 63941-253 |