Prescription drug · NDA AUTHORIZED GENERIC
Spinosad NDC 52246-570
Spinosad 9 mg/mL · Suspension · Topical · ParaPRO LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52246-570-04 | 52246057004 | 1 BOTTLE, PLASTIC in 1 CARTON (52246-570-04) / 120 mL in 1 BOTTLE, PLASTICMarketed from Jan 29, 2024 |
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)
- Spinosad
- Generic name (nonproprietary)
- spinosad
- Active ingredients
- Spinosad — 9 mg/mL
- Dosage form
- Suspension
- Route
- Topical
- Labeler
- ParaPRO LLCNDC labeler code 52246
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022408
- Marketing start
- Listing expires
- Identifiers
- Product ID 52246-570_f2a068ae-4f02-4647-bb8d-052f82dd8d87SPL ID f2a068ae-4f02-4647-bb8d-052f82dd8d87SPL set ID 0d6e2507-3669-441e-b5ba-86087fd2955dRxCUI 1085816UNII XPA88EAP6VUPC 0352246570046
- Pharmacologic class
- Pediculicide
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
N452246057004followed by a unit qualifier and the quantityPackage 52246-0570-04. 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)
Spinosad Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. ( 1.1 ) Spinosad Topical Suspension is a scabicide indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older. ( 1.2 ) 1.1 Head Lice Infestations Spinosad Topical Suspension is indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. Adjunctive Measures for Head Lice Infestations Spinosad Topical Suspension should be used in the context of an overall lice management program: Wash in hot water or dry-clean al…
Excerpt only. Read the full label for complete information.
About NDC 52246-570
- What is NDC 52246-570?
- 52246-570 is the product NDC for Spinosad, Spinosad 9 mg/mL suspension, listed with the FDA by ParaPRO LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Spinosad.
- What is the active ingredient?
- Spinosad.
- Who is the labeler?
- ParaPRO LLC, NDC labeler code 52246. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Spinosad?
- 2 other product NDCs are listed under this name. See all Spinosad NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Spinosad products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Spinosad | Spinosad 9 mg/mL | SuspensionTopical | Cipher Pharmaceuticals Inc. | 84635-570 | 84635-0570-04 |
| Spinosad | Spinosad 9 mg/mL | SuspensionTopical | Allegis Pharmaceuticals, LLC | 28595-570 | 28595-0570-04 |
Other NDCs under NDA 022408
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 |
|---|---|---|---|---|
| Natrobaspinosad | Spinosad 9 mg/mL | SuspensionTopical | ParaPRO LLC | 52246-929 |
| Spinosad | Spinosad 9 mg/mL | SuspensionTopical | Allegis Pharmaceuticals, LLC | 28595-570 |
| Spinosad | Spinosad 9 mg/mL | SuspensionTopical | Cipher Pharmaceuticals Inc. | 84635-570 |
| Natrobaspinosad | Spinosad 9 mg/mL | SuspensionTopical | Cipher Pharmaceuticals Inc. | 84635-929 |