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United States · US · US:63187-274_8ef3522a-3a22-4d52-852d-a18f5a78f482
Baclofen
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11631872743030 TABLET in 1 BOTTLE (63187-274-30)
- ndc11631872746060 TABLET in 1 BOTTLE (63187-274-60)
- ndc11631872749090 TABLET in 1 BOTTLE (63187-274-90)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A072235
AB
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": "63187-274_8ef3522a-3a22-4d52-852d-a18f5a78f482",
"productndc": "63187-274",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "072235",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Jul 21, 1988"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "Baclofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA072235",
"marketing_category": "ANDA",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "19880721",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code M03BX01.
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