pramipexole dihydrochloride

Orange BookUNIISPLATC N04BC05

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

Identification

ManufacturerStrides Pharma Science Limited

CountryUS (United States)

ATC codeN04BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6438075101
10 BLISTER PACK in 1 CARTON (64380-751-01) / 10 TABLET in 1 BLISTER PACK
ndc11
6438075105
90 TABLET in 1 BOTTLE (64380-751-05)

Annotations

UNII (FDA Substance ID)

3D867NP06J

PRAMIPEXOLE DIHYDROCHLORIDE

RxCUI 236747

Orange Book

A202702

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": "64380-751_94664b38-edd0-4181-8eb2-8bbd9aa3a451",
  "productndc": "64380-751",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202702",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.125MG",
        "product_no": "001",
        "approval_date": "Jun 3, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "002",
        "approval_date": "Jun 3, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "003",
        "approval_date": "Jun 3, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.75MG",
        "product_no": "004",
        "approval_date": "Jun 3, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "005",
        "approval_date": "Jun 3, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.5MG",
        "product_no": "006",
        "approval_date": "Jun 3, 2014"
      }
    ],
    "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": "ANDA202702",
  "marketing_category": "ANDA",
  "nonproprietary_name": "pramipexole dihydrochloride",
  "start_marketing_date": "20210215",
  "active_numerator_strength": "1.5"
}

Related drugs

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