Pramipexole dihydrochloride

Orange BookUNIISPLATC N04BC05

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

Identification

ManufacturerIngenus Pharmaceuticals, LLC

CountryUS (United States)

ATC codeN04BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5074233330
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-333-30)

Annotations

UNII (FDA Substance ID)

3D867NP06J

PRAMIPEXOLE DIHYDROCHLORIDE

RxCUI 236747

Orange Book

A213444

ABABABABABABAB

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": "50742-333_74c3457e-079c-4b2b-bae4-3f148540a27a",
  "productndc": "50742-333",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "213444",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.375MG",
        "product_no": "001",
        "approval_date": "Feb 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.75MG",
        "product_no": "002",
        "approval_date": "Feb 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.5MG",
        "product_no": "003",
        "approval_date": "Feb 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.25MG",
        "product_no": "004",
        "approval_date": "Feb 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "005",
        "approval_date": "Feb 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3.75MG",
        "product_no": "006",
        "approval_date": "Feb 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4.5MG",
        "product_no": "007",
        "approval_date": "Feb 3, 2022"
      }
    ],
    "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": "ANDA213444",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pramipexole dihydrochloride",
  "start_marketing_date": "20220310",
  "active_numerator_strength": "1.5"
}

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