Pramipexole dihydrochloride

Orange BookUNIISPLATC N04BC05

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeN04BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6846262705
500 TABLET in 1 BOTTLE (68462-627-05)
ndc11
6846262790
90 TABLET in 1 BOTTLE (68462-627-90)

Annotations

UNII (FDA Substance ID)

3D867NP06J

PRAMIPEXOLE DIHYDROCHLORIDE

RxCUI 236747

Orange Book

A090781

ABABABABABAB

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": "68462-627_75644134-fcad-4dde-8a22-453d18472002",
  "productndc": "68462-627",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090781",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.125MG",
        "product_no": "001",
        "approval_date": "Oct 8, 2010"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "002",
        "approval_date": "Oct 8, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "003",
        "approval_date": "Oct 8, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "004",
        "approval_date": "Oct 8, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.5MG",
        "product_no": "005",
        "approval_date": "Oct 8, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.75MG",
        "product_no": "006",
        "approval_date": "Sep 11, 2015"
      }
    ],
    "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": "ANDA090781",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pramipexole dihydrochloride",
  "start_marketing_date": "20160131",
  "active_numerator_strength": ".75"
}

Related drugs

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