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United States · US · US:60429-085_494fcbc6-e427-a591-e063-6394a90ae5df
Pramipexole Dihydrochloride
Orange BookUNIISPLATC N04BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGolden State Medical Supply, Inc.
CountryUS (United States)
ATC codeN04BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11604290859090 TABLET in 1 BOTTLE (60429-085-90)
Annotations
UNII (FDA Substance ID)
3D867NP06J
PRAMIPEXOLE DIHYDROCHLORIDE
RxCUI 236747
Orange Book
A203855
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": "60429-085_494fcbc6-e427-a591-e063-6394a90ae5df",
"productndc": "60429-085",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203855",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.125MG",
"product_no": "001",
"approval_date": "Oct 28, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.25MG",
"product_no": "002",
"approval_date": "Oct 28, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "003",
"approval_date": "Oct 28, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.75MG",
"product_no": "004",
"approval_date": "Oct 28, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "005",
"approval_date": "Oct 28, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1.5MG",
"product_no": "006",
"approval_date": "Oct 28, 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": "ANDA203855",
"marketing_category": "ANDA",
"nonproprietary_name": "Pramipexole Dihydrochloride",
"start_marketing_date": "20141028",
"active_numerator_strength": ".125"
}Related drugs
Other records sharing ATC code N04BC05.
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