Ropinirole

Orange BookUNIISPLATC N04BC04

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

Identification

ManufacturerDr. Reddys Laboratories Limited

CountryUS (United States)

ATC codeN04BC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5511172805
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-728-05)
ndc11
5511172830
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-728-30)
ndc11
5511172890
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-728-90)

Annotations

UNII (FDA Substance ID)

D7ZD41RZI9

ROPINIROLE HYDROCHLORIDE

RxCUI 236553

Orange Book

A201576

ABABABABAB

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": "55111-728_78d63517-2d1a-fc70-4ffb-3ebbfa065218",
  "productndc": "55111-728",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "201576",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Jun 6, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Jun 6, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 6MG BASE",
        "product_no": "003",
        "approval_date": "Jun 6, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "004",
        "approval_date": "Jun 6, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12MG BASE",
        "product_no": "005",
        "approval_date": "Jun 6, 2012"
      }
    ],
    "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": "ANDA201576",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ropinirole",
  "start_marketing_date": "20120606",
  "active_numerator_strength": "12"
}

Related drugs

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