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United States · US · US:57237-110_9ea82ae9-2d77-4da4-8213-dda2434df9d7

Felodipine

Orange BookUNIISPLATC C08CA02

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeC08CA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5723711001
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-110-01)

Annotations

UNII (FDA Substance ID)
OL961R6O2C
FELODIPINE
RxCUI 4316
Orange Book
A203417
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "OL961R6O2C",
    "rxcui": "4316",
    "inchikey": "RZTAMFZIAATZDJ-UHFFFAOYSA-N",
    "display_name": "FELODIPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "60fb803e-ccf7-46f2-b506-e157ce440f87": {
      "match": "brand_token",
      "title": "FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]",
      "spl_version": "8",
      "published_date": "2026-03-02"
    }
  },
  "productid": "57237-110_9ea82ae9-2d77-4da4-8213-dda2434df9d7",
  "productndc": "57237-110",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203417",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Jan 17, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Jan 17, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Jan 17, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FELODIPINE",
  "proprietary_name": "Felodipine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203417",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Felodipine",
  "start_marketing_date": "20130117",
  "active_numerator_strength": "10"
}

Related drugs

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