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United States · US · US:80425-0568_46416b23-1e60-f4e3-e063-6294a90a953f
BACLOFEN
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11804250568130 TABLET in 1 BOTTLE, PLASTIC (80425-0568-1)
- ndc11804250568260 TABLET in 1 BOTTLE, PLASTIC (80425-0568-2)
- ndc11804250568390 TABLET in 1 BOTTLE, PLASTIC (80425-0568-3)
- ndc118042505684120 TABLET in 1 BOTTLE, PLASTIC (80425-0568-4)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A209102
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "H789N3FKE8",
"rxcui": "1292",
"inchikey": "KPYSYYIEGFHWSV-UHFFFAOYSA-N",
"display_name": "BACLOFEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e017a001-8cb1-4dd8-960e-c6d74005f57f": {
"match": "brand_token",
"title": "BACLOFEN TABLET [REMEDYREPACK INC.]",
"spl_version": "1",
"published_date": "2026-05-13"
}
},
"productid": "80425-0568_46416b23-1e60-f4e3-e063-6294a90a953f",
"productndc": "80425-0568",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209102",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Nov 28, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Nov 28, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "Nov 28, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "004",
"approval_date": "Feb 5, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "BACLOFEN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209102",
"marketing_category": "ANDA",
"nonproprietary_name": "BACLOFEN",
"start_marketing_date": "20251210",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03BX01.
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