ropinirole

Orange BookUNIISPLATC N04BC04

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN04BC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7133512311
30 TABLET, FILM COATED in 1 BOTTLE (71335-1231-1)
ndc11
7133512312
60 TABLET, FILM COATED in 1 BOTTLE (71335-1231-2)
ndc11
7133512313
28 TABLET, FILM COATED in 1 BOTTLE (71335-1231-3)
ndc11
7133512314
100 TABLET, FILM COATED in 1 BOTTLE (71335-1231-4)

Annotations

UNII (FDA Substance ID)

D7ZD41RZI9

ROPINIROLE HYDROCHLORIDE

RxCUI 236553

Orange Book

A204022

ABABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "D7ZD41RZI9",
    "rxcui": "236553",
    "inchikey": "XDXHAEQXIBQUEZ-UHFFFAOYSA-N",
    "display_name": "ROPINIROLE HYDROCHLORIDE",
    "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": "71335-1231_1c85c85d-fe34-4795-96c2-ad2fbf428a7a",
  "productndc": "71335-1231",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204022",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.25MG BASE",
        "product_no": "001",
        "approval_date": "Feb 28, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "002",
        "approval_date": "Feb 28, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "003",
        "approval_date": "Feb 28, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "004",
        "approval_date": "Feb 28, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 3MG BASE",
        "product_no": "005",
        "approval_date": "Feb 28, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "006",
        "approval_date": "Feb 28, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "007",
        "approval_date": "Feb 28, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROPINIROLE HYDROCHLORIDE",
  "proprietary_name": "ropinirole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204022",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ropinirole",
  "start_marketing_date": "20181017",
  "active_numerator_strength": ".25"
}

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