Felodipine

Orange BookUNIISPLATC C08CA02

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

Identification

ManufacturerTorrent Pharmaceuticals Limited

CountryUS (United States)

ATC codeC08CA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
1366813301
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-133-01)
ndc11
1366813305
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-133-05)
ndc11
1366813310
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-133-10)
ndc11
1366813330
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-133-30)
ndc11
1366813390
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-133-90)

Annotations

UNII (FDA Substance ID)

OL961R6O2C

FELODIPINE

RxCUI 4316

Orange Book

A202170

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": "13668-133_788121c3-8ac5-4592-b1c7-55466b849cce",
  "productndc": "13668-133",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "202170",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Nov 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Nov 28, 2011"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Nov 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": "ANDA202170",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Felodipine",
  "start_marketing_date": "20111128",
  "active_numerator_strength": "5"
}

Related drugs

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