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United States · US · US:49884-231_16be47d2-4bd1-4410-a633-476cdbbbceec

PRAZIQUANTEL

Orange BookUNIISPLATC P02BA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeP02BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4988423183
    6 TABLET, FILM COATED in 1 BOTTLE (49884-231-83)

Annotations

UNII (FDA Substance ID)
6490C9U457
PRAZIQUANTEL
RxCUI 8628
Orange Book
A208820
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6490C9U457",
    "rxcui": "8628",
    "inchikey": "FSVJFNAIGNNGKK-UHFFFAOYSA-N",
    "display_name": "PRAZIQUANTEL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3d13a4f4-3df5-489b-9fa3-07e728e02f0f": {
      "match": "brand_token",
      "title": "PRAZIQUANTEL TABLET, CHEWABLE [FELIX PHARMACEUTICALS PRIVATE LIMITED]",
      "spl_version": "1",
      "published_date": "2026-01-28"
    }
  },
  "productid": "49884-231_16be47d2-4bd1-4410-a633-476cdbbbceec",
  "productndc": "49884-231",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208820",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Nov 27, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRAZIQUANTEL",
  "proprietary_name": "PRAZIQUANTEL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208820",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PRAZIQUANTEL",
  "start_marketing_date": "20171127",
  "active_numerator_strength": "600"
}

Related drugs

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