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United States · US · US:68788-8726_14664cc5-700a-44e4-bd73-b8f4cbd8c1e8
BACLOFEN
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116878887261100 TABLET in 1 BOTTLE (68788-8726-1)
- ndc11687888726330 TABLET in 1 BOTTLE (68788-8726-3)
- ndc11687888726660 TABLET in 1 BOTTLE (68788-8726-6)
- ndc116878887268120 TABLET in 1 BOTTLE (68788-8726-8)
- ndc11687888726990 TABLET in 1 BOTTLE (68788-8726-9)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A214374
ABABAB
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": "68788-8726_14664cc5-700a-44e4-bd73-b8f4cbd8c1e8",
"productndc": "68788-8726",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214374",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Mar 5, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Mar 5, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "Mar 5, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "BACLOFEN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214374",
"marketing_category": "ANDA",
"nonproprietary_name": "BACLOFEN",
"start_marketing_date": "20240816",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03BX01.
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