spinosad

Generic: spinosad

Labeler: cipher pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name spinosad
Generic Name spinosad
Labeler cipher pharmaceuticals inc.
Dosage Form SUSPENSION
Routes
TOPICAL
Active Ingredients

spinosad 9 mg/mL

Manufacturer
Cipher Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 84635-570
Product ID 84635-570_4c375471-7b53-757f-e063-6294a90a8065
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022408
Listing Expiration 2027-12-31
Marketing Start 2024-01-29

Pharmacologic Class

Established (EPC)
pediculicide [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84635570
Hyphenated Format 84635-570

Supplemental Identifiers

RxCUI
1085816
UNII
XPA88EAP6V
NUI
N0000181811

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name spinosad (source: ndc)
Generic Name spinosad (source: ndc)
Application Number NDA022408 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 9 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (84635-570-04) / 120 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

84635-570-04 1 BOTTLE, PLASTIC in 1 CARTON (84635-570-04) / 120 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

spinosad (9 mg/mL)

Linked Drug Pages (1)

Spinosad ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4c375471-7b53-757f-e063-6294a90a8065", "openfda": {"nui": ["N0000181811"], "unii": ["XPA88EAP6V"], "rxcui": ["1085816"], "spl_set_id": ["16a95039-0df7-45d5-8b51-bbc81443fea3"], "pharm_class_epc": ["Pediculicide [EPC]"], "manufacturer_name": ["Cipher Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (84635-570-04)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "84635-570-04", "marketing_start_date": "20260119"}], "brand_name": "Spinosad", "product_id": "84635-570_4c375471-7b53-757f-e063-6294a90a8065", "dosage_form": "SUSPENSION", "pharm_class": ["Pediculicide [EPC]"], "product_ndc": "84635-570", "generic_name": "spinosad", "labeler_name": "Cipher Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spinosad", "active_ingredients": [{"name": "SPINOSAD", "strength": "9 mg/mL"}], "application_number": "NDA022408", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240129", "listing_expiration_date": "20271231"}