ropinirole hydrochloride

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 · 2

ndc11
4354760010
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-600-10)
ndc11
4354760050
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-600-50)

Annotations

UNII (FDA Substance ID)

D7ZD41RZI9

ROPINIROLE HYDROCHLORIDE

RxCUI 236553

Orange Book

A078110

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": "43547-600_bb48dd84-da25-4221-bdc7-2039e4300ed3",
  "productndc": "43547-600",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078110",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.25MG BASE",
        "product_no": "001",
        "approval_date": "May 5, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "002",
        "approval_date": "May 5, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "003",
        "approval_date": "May 5, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "004",
        "approval_date": "May 5, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 3MG BASE",
        "product_no": "005",
        "approval_date": "May 5, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "006",
        "approval_date": "May 5, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "007",
        "approval_date": "Jul 11, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROPINIROLE HYDROCHLORIDE",
  "proprietary_name": "ropinirole hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078110",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ropinirole hydrochloride",
  "start_marketing_date": "20110920",
  "active_numerator_strength": "4"
}

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