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United States · US · US:66267-831_1fa79245-277f-9b81-e063-6294a90ab7cb

Nifedipine

Orange BookUNIISPLATC C08CA05

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

Identification

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

Packs · 1

  • ndc11
    6626783104
    4 CAPSULE in 1 BOTTLE (66267-831-04)

Annotations

UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A072781
AB
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": "66267-831_1fa79245-277f-9b81-e063-6294a90ab7cb",
  "productndc": "66267-831",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "072781",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jul 30, 1993"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NIFEDIPINE",
  "proprietary_name": "Nifedipine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA072781",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nifedipine",
  "start_marketing_date": "20090811",
  "active_numerator_strength": "10"
}

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