Felodipine

Orange BookUNIISPLATC C08CA02

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

Identification

ManufacturerEndo USA, Inc.

CountryUS (United States)

ATC codeC08CA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0603358321
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3583-21)
ndc11
0603358328
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3583-28)

Annotations

UNII (FDA Substance ID)

OL961R6O2C

FELODIPINE

RxCUI 4316

Orange Book

A200815

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": "0603-3583_ca215c73-f6f1-492c-810c-876e46001086",
  "productndc": "0603-3583",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "200815",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Oct 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Oct 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Oct 28, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FELODIPINE",
  "proprietary_name": "Felodipine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA200815",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Felodipine",
  "start_marketing_date": "20111215",
  "active_numerator_strength": "10"
}

Related drugs

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