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United States · US · US:66993-141_9a21dde8-cd39-400b-933a-a74e907ffcba

Aliskiren

Orange BookUNIISPLATC C09XA02

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

Identification

ManufacturerPrasco Laboratories
CountryUS (United States)
ATC codeC09XA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6699314130
    30 TABLET, FILM COATED in 1 BOTTLE (66993-141-30)

Annotations

UNII (FDA Substance ID)
C8A0P8G029
ALISKIREN HEMIFUMARATE
RxCUI 732498
Orange Book
N021985
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "C8A0P8G029",
    "rxcui": "732498",
    "inchikey": "KLRSDBSKUSSCGU-KRQUFFFQSA-N",
    "display_name": "ALISKIREN HEMIFUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f3fd2503-25ef-4660-a29a-f62c491e28fb": {
      "match": "brand_token",
      "title": "ALISKIREN TABLET, FILM COATED [ENDO USA, INC.]",
      "spl_version": "29",
      "published_date": "2024-09-26"
    }
  },
  "productid": "66993-141_9a21dde8-cd39-400b-933a-a74e907ffcba",
  "productndc": "66993-141",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021985",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Mar 5, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "002",
        "approval_date": "Mar 5, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALISKIREN HEMIFUMARATE",
  "proprietary_name": "Aliskiren",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021985",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "aliskiren hemifumarate",
  "start_marketing_date": "20190304",
  "active_numerator_strength": "150"
}

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