Nifedipine

Orange BookUNIISPLATC C08CA05

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

Identification

ManufacturerChartwell RX, LLC

CountryUS (United States)

ATC codeC08CA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6213552390
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62135-523-90)

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": "62135-523_462a6c34-db5b-8d31-e063-6294a90ae196",
  "productndc": "62135-523",
  "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": "20071003",
  "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