Ropinirole

Orange BookUNIISPLATC N04BC04

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeN04BC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
4670826410
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (46708-264-10)
ndc11
4670826430
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-30)
ndc11
4670826431
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-31)
ndc11
4670826471
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-71)
ndc11
4670826490
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-90)
ndc11
4670826491
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-91)

Annotations

UNII (FDA Substance ID)

D7ZD41RZI9

ROPINIROLE HYDROCHLORIDE

RxCUI 236553

Orange Book

A202786

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": "46708-264_a1e5da4e-74fc-4482-8e15-599c665f2c2f",
  "productndc": "46708-264",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "202786",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Apr 22, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Apr 22, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 6MG BASE",
        "product_no": "003",
        "approval_date": "Apr 22, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "004",
        "approval_date": "Apr 22, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12MG BASE",
        "product_no": "005",
        "approval_date": "Apr 22, 2013"
      }
    ],
    "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": "ANDA202786",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ropinirole",
  "start_marketing_date": "20130314",
  "active_numerator_strength": "6"
}

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