Pramipexole Dihydrochloride

Orange BookUNIISPLATC N04BC05

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

Identification

ManufacturerVitruvias Therapeutics, Inc.

CountryUS (United States)

ATC codeN04BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6968014530
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-145-30)

Annotations

UNII (FDA Substance ID)

3D867NP06J

PRAMIPEXOLE DIHYDROCHLORIDE

RxCUI 236747

Orange Book

A212797

ABAB

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": "69680-145_232ae12c-b9bc-4ca7-982e-d6f43b6c8eec",
  "productndc": "69680-145",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "212797",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.375MG",
        "product_no": "001",
        "approval_date": "Jun 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.75MG",
        "product_no": "002",
        "approval_date": "Jun 11, 2021"
      }
    ],
    "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": "ANDA212797",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pramipexole Dihydrochloride",
  "start_marketing_date": "20210827",
  "active_numerator_strength": ".375"
}

Related drugs

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