Nifedipine

Orange BookUNIISPLATC C08CA05

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC08CA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7278948601
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-486-01)

Annotations

UNII (FDA Substance ID)

I9ZF7L6G2L

NIFEDIPINE

RxCUI 7417

Orange Book

A216067

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": "72789-486_47bfdd27-82a6-09b7-e063-6294a90acc43",
  "productndc": "72789-486",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "216067",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Mar 29, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Mar 29, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "90MG",
        "product_no": "003",
        "approval_date": "Mar 29, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NIFEDIPINE",
  "proprietary_name": "Nifedipine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216067",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nifedipine",
  "start_marketing_date": "20220330",
  "active_numerator_strength": "90"
}

Related drugs

Other records sharing ATC code C08CA05.

Access this data programmatically

Query Nifedipine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs