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Medicine

Spinosad 9 mg/mL topical suspension

Spinosad · Topical
Available on requestPrescription onlyUS FDAGeneric name

Spinosad 9 mg/mL topical suspension is a generic prescription medicine for topical use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 25° C (77° F), excursions permitted to 15° to 30° C (59° to 86° F).

Key facts

Active ingredient (INN)
Spinosad
Brand
Sold under the generic name
Strength
9 mg/mL
Dosage form
Topical suspension
Route
Topical
Packs
1 bottle
Manufacturers
Allegis PharmaceuticalsCipher PharmaceuticalsParaPRO
Origin register
US FDA, United States
Storage
Store at 25° C (77° F), excursions permitted to 15° to 30° C (59° to 86° F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
25 June 2014
Identifiers
RxCUI 1085816DailyMed set ID 16a95039-0df7-45d5-8b51-bbc81443fea3, 0d6e2507-3669-441e-b5ba-86087fd2955d, 8e87bd3b-db25-4e97-bf57-96c875f67ce1NDC 84635-570, 52246-570, 28595-570Application NDA022408

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
1 bottle, plastic in 1 carton / 120 mL in 1 bottle, plastic28595-570-04Allegis Pharmaceuticals25 June 2014
1 bottle, plastic in 1 carton / 120 mL in 1 bottle, plastic84635-570-04Cipher Pharmaceuticals19 January 2026
1 bottle, plastic in 1 carton / 120 mL in 1 bottle, plastic52246-570-04ParaPRO29 January 2024

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 18 January 2011Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Spinosad 9 mg/mL topical suspension.

Compare 1

Clinical summary

Spinosad is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older, among other approved uses. It is available as topical suspension. MedsAcross supplies Spinosad for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Spinosad

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Spinosad 9 mg/mL topical suspension for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.