ROPINIROLE HYDROCHLORIDE

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 · 5

ndc11
7133508291
30 TABLET, FILM COATED in 1 BOTTLE (71335-0829-1)
ndc11
7133508292
28 TABLET, FILM COATED in 1 BOTTLE (71335-0829-2)
ndc11
7133508293
90 TABLET, FILM COATED in 1 BOTTLE (71335-0829-3)
ndc11
7133508294
60 TABLET, FILM COATED in 1 BOTTLE (71335-0829-4)
ndc11
7133508295
100 TABLET, FILM COATED in 1 BOTTLE (71335-0829-5)

Annotations

UNII (FDA Substance ID)

D7ZD41RZI9

ROPINIROLE HYDROCHLORIDE

RxCUI 236553

Orange Book

A090429

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": "71335-0829_19c09308-7bea-4f2e-93d5-d635e4c6fdf5",
  "productndc": "71335-0829",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090429",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.25MG BASE",
        "product_no": "001",
        "approval_date": "Mar 24, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "002",
        "approval_date": "Mar 24, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "003",
        "approval_date": "Mar 24, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "004",
        "approval_date": "Mar 24, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 3MG BASE",
        "product_no": "005",
        "approval_date": "Mar 24, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "006",
        "approval_date": "Mar 24, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "007",
        "approval_date": "Mar 24, 2010"
      }
    ],
    "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": "ANDA090429",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ROPINIROLE HYDROCHLORIDE",
  "start_marketing_date": "20160129",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N04BC04.

Access this data programmatically

Query ROPINIROLE HYDROCHLORIDE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs