Nifedipine

Orange BookUNIISPLATC C08CA05

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

Identification

ManufacturerMajor Pharmaceuticals

CountryUS (United States)

ATC codeC08CA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0904708106
50 BLISTER PACK in 1 CARTON (0904-7081-06) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
0904708161
100 BLISTER PACK in 1 CARTON (0904-7081-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

I9ZF7L6G2L

NIFEDIPINE

RxCUI 7417

Orange Book

A210614

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": "0904-7081_af49dd32-02ac-47ab-b513-ca480fe8dc36",
  "productndc": "0904-7081",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210614",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Mar 12, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Mar 12, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB2",
        "strength": "90MG",
        "product_no": "003",
        "approval_date": "Mar 12, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NIFEDIPINE",
  "proprietary_name": "Nifedipine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210614",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nifedipine",
  "start_marketing_date": "20190312",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code C08CA05.

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