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United States · US · US:49884-347_2a1e4060-1340-49c7-86f9-9f4206124b3d

Pimozide

Orange BookUNIISPLATC N05AG02

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

Identification

ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeN05AG02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4988434701
    100 TABLET in 1 BOTTLE (49884-347-01)

Annotations

UNII (FDA Substance ID)
1HIZ4DL86F
PIMOZIDE
RxCUI 8331
Orange Book
A204521
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1HIZ4DL86F",
    "rxcui": "8331",
    "inchikey": "YVUQSNJEYSNKRX-UHFFFAOYSA-N",
    "display_name": "PIMOZIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4e954fc2-fdff-486c-beb6-2b8ace717081": {
      "match": "brand_token",
      "title": "PIMOZIDE TABLET [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2026-05-21"
    }
  },
  "productid": "49884-347_2a1e4060-1340-49c7-86f9-9f4206124b3d",
  "productndc": "49884-347",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204521",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2015"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Sep 28, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PIMOZIDE",
  "proprietary_name": "Pimozide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204521",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pimozide",
  "start_marketing_date": "20150928",
  "active_numerator_strength": "1"
}

Related drugs

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