ropinirole

Orange BookUNIISPLATC N04BC04

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeN04BC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7051834780
30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3478-0)
ndc11
7051834781
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-1)
ndc11
7051834782
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-2)
ndc11
7051834783
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-3)

Annotations

UNII (FDA Substance ID)

D7ZD41RZI9

ROPINIROLE HYDROCHLORIDE

RxCUI 236553

Orange Book

A090135

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": "70518-3478_4c9d34b8-c7bd-a9fa-e063-6294a90aad46",
  "productndc": "70518-3478",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090135",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.25MG BASE",
        "product_no": "001",
        "approval_date": "Feb 25, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "002",
        "approval_date": "Feb 25, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "003",
        "approval_date": "Feb 25, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "004",
        "approval_date": "Feb 25, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 3MG BASE",
        "product_no": "005",
        "approval_date": "Feb 25, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "006",
        "approval_date": "Feb 25, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "007",
        "approval_date": "Feb 25, 2010"
      }
    ],
    "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": "ANDA090135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ropinirole",
  "start_marketing_date": "20220817",
  "active_numerator_strength": ".5"
}

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