Nifedipine

Orange BookUNIISPLATC C08CA05

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeC08CA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
7120596500
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-00)
ndc11
7120596530
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-30)
ndc11
7120596560
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-60)
ndc11
7120596564
240 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-64)
ndc11
7120596567
270 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-67)
ndc11
7120596572
120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-72)
ndc11
7120596578
180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-78)
ndc11
7120596590
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-90)
ndc11
7120596596
300 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-96)

Annotations

UNII (FDA Substance ID)

I9ZF7L6G2L

NIFEDIPINE

RxCUI 7417

Orange Book

A203126

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": "71205-965_ba67d6b0-f638-4264-9bd4-1557223abe83",
  "productndc": "71205-965",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203126",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Apr 3, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Apr 3, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "90MG",
        "product_no": "003",
        "approval_date": "Apr 3, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NIFEDIPINE",
  "proprietary_name": "Nifedipine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203126",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nifedipine",
  "start_marketing_date": "20141101",
  "active_numerator_strength": "90"
}

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