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United States · US · US:0069-2660_c24a0478-46d4-413a-8d48-c21af0bc10e4

Procardia

Orange BookUNIISPLATC C08CA05

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

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeC08CA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0069266041
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0069-2660-41)
  • ndc11
    0069266066
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-2660-66)

Annotations

UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
N019684
AB2AB2
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": {
    "8ebcb33c-f43b-4b36-9f94-9774b2a59e06": {
      "match": "brand_token",
      "title": "PROCARDIA XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "19",
      "published_date": "2025-12-17"
    }
  },
  "productid": "0069-2660_c24a0478-46d4-413a-8d48-c21af0bc10e4",
  "productndc": "0069-2660",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "019684",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Sep 6, 1989"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Sep 6, 1989"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "90MG",
        "product_no": "003",
        "approval_date": "Sep 6, 1989"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NIFEDIPINE",
  "proprietary_name": "Procardia",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019684",
  "marketing_category": "NDA",
  "nonproprietary_name": "nifedipine",
  "start_marketing_date": "19890906",
  "active_numerator_strength": "60"
}

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