Pramipexole dihydrochloride

Orange BookUNIISPLATC N04BC05

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeN04BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
3334203506
30 BLISTER PACK in 1 CARTON (33342-035-06) / 1 TABLET in 1 BLISTER PACK
ndc11
3334203510
90 TABLET in 1 BOTTLE (33342-035-10)
ndc11
3334203512
100 BLISTER PACK in 1 CARTON (33342-035-12) / 1 TABLET in 1 BLISTER PACK
ndc11
3334203515
500 TABLET in 1 BOTTLE (33342-035-15)

Annotations

UNII (FDA Substance ID)

3D867NP06J

PRAMIPEXOLE DIHYDROCHLORIDE

RxCUI 236747

Orange Book

A202164

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3D867NP06J",
    "rxcui": "236747",
    "inchikey": "APVQOOKHDZVJEX-QTPLPEIMSA-N",
    "display_name": "PRAMIPEXOLE DIHYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "46f88017-7b0e-437e-90b1-37bdf9013e72": {
      "match": "brand_token",
      "title": "PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-05-25"
    }
  },
  "productid": "33342-035_721c81fc-fd21-4d86-ab96-9a329b8e015b",
  "productndc": "33342-035",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202164",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.125MG",
        "product_no": "001",
        "approval_date": "Sep 20, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.25MG",
        "product_no": "002",
        "approval_date": "Sep 20, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.5MG",
        "product_no": "003",
        "approval_date": "Sep 20, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG",
        "product_no": "004",
        "approval_date": "Sep 20, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.5MG",
        "product_no": "005",
        "approval_date": "Sep 20, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRAMIPEXOLE DIHYDROCHLORIDE",
  "proprietary_name": "Pramipexole dihydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202164",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pramipexole dihydrochloride",
  "start_marketing_date": "20120921",
  "active_numerator_strength": "1.5"
}

Related drugs

Other records sharing ATC code N04BC05.

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