ROPINIROLE

Orange BookUNIISPLATC N04BC04

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

Identification

ManufacturerSolco Healthcare US, LLC

CountryUS (United States)

ATC codeN04BC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4354755403
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-554-03)

Annotations

UNII (FDA Substance ID)

030PYR8953

ROPINIROLE

RxCUI 72302

Orange Book

A204413

ABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "030PYR8953",
    "rxcui": "72302",
    "inchikey": "UHSKFQJFRQCDBE-UHFFFAOYSA-N",
    "display_name": "ROPINIROLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c89f68e5-d2ad-4aad-a63c-c32eff5e82c9": {
      "match": "brand_token",
      "title": "ROPINIROLE TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "101",
      "published_date": "2026-06-01"
    }
  },
  "productid": "43547-554_9bbec058-00a5-4353-bd58-426ddb0b2020",
  "productndc": "43547-554",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204413",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "May 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "May 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 6MG BASE",
        "product_no": "003",
        "approval_date": "May 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "004",
        "approval_date": "May 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12MG BASE",
        "product_no": "005",
        "approval_date": "May 11, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROPINIROLE",
  "proprietary_name": "ROPINIROLE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204413",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ropinirole",
  "start_marketing_date": "20220322",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N04BC04.

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