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United States · US · US:62175-261_2b91b384-4c20-4162-a717-9dc53ea834cc

Nifedipine

Orange BookUNIISPLATC C08CA05

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

Identification

ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeC08CA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6217526137
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-261-37)
  • ndc11
    6217526146
    90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-261-46)
  • ndc11
    6217526155
    300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-261-55)

Annotations

UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A077127
AB2AB2AB2
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "I9ZF7L6G2L",
    "rxcui": "7417",
    "inchikey": "HYIMSNHJOBLJNT-UHFFFAOYSA-N",
    "display_name": "NIFEDIPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "518d39af-0be1-acbc-e063-6294a90a4ada": {
      "match": "brand_token",
      "title": "NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-13"
    }
  },
  "productid": "62175-261_2b91b384-4c20-4162-a717-9dc53ea834cc",
  "productndc": "62175-261",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "077127",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Nov 21, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Nov 21, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "90MG",
        "product_no": "003",
        "approval_date": "Oct 3, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NIFEDIPINE",
  "proprietary_name": "Nifedipine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077127",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nifedipine",
  "start_marketing_date": "20051121",
  "active_numerator_strength": "60"
}

Related drugs

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