Spinosad

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCipher Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8463557004
1 BOTTLE, PLASTIC in 1 CARTON (84635-570-04) / 120 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

XPA88EAP6V

SPINOSAD

RxCUI 299081

Orange Book

N022408

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "XPA88EAP6V",
    "rxcui": "299081",
    "inchikey": null,
    "display_name": "SPINOSAD",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "16a95039-0df7-45d5-8b51-bbc81443fea3": {
      "match": "brand_token",
      "title": "SPINOSAD SUSPENSION [CIPHER PHARMACEUTICALS INC.]",
      "spl_version": "2",
      "published_date": "2026-03-05"
    }
  },
  "productid": "84635-570_4c375471-7b53-757f-e063-6294a90a8065",
  "productndc": "84635-570",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "022408",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.9%",
        "product_no": "001",
        "approval_date": "Jan 18, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SPINOSAD",
  "proprietary_name": "Spinosad",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022408",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "spinosad",
  "start_marketing_date": "20240129",
  "active_numerator_strength": "9"
}

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