Felodipine

Orange BookUNIISPLATC C08CA02

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeC08CA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6846223401
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-234-01)
ndc11
6846223410
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-234-10)
ndc11
6846223411
10 BLISTER PACK in 1 CARTON (68462-234-11) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
6846223490
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-234-90)

Annotations

UNII (FDA Substance ID)

OL961R6O2C

FELODIPINE

RxCUI 4316

Orange Book

A090365

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": "68462-234_8663994d-841f-427a-93db-b4c9d10bad27",
  "productndc": "68462-234",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090365",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Dec 17, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Dec 17, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Dec 17, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FELODIPINE",
  "proprietary_name": "Felodipine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090365",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Felodipine",
  "start_marketing_date": "20101220",
  "active_numerator_strength": "5"
}

Related drugs

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