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United States · US · US:71930-007_7d9fb520-b11c-4e80-b2c8-1f642d5e78d4
Baclofen
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEywa Pharma Inc
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117193000712100 TABLET in 1 BOTTLE (71930-007-12)
- ndc1171930007131000 TABLET in 1 BOTTLE (71930-007-13)
- ndc117193000752500 TABLET in 1 BOTTLE (71930-007-52)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A211555
BXBXBX
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": "71930-007_7d9fb520-b11c-4e80-b2c8-1f642d5e78d4",
"productndc": "71930-007",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211555",
"products": [
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "10MG",
"product_no": "001",
"approval_date": "Feb 1, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "20MG",
"product_no": "002",
"approval_date": "Feb 1, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "5MG",
"product_no": "003",
"approval_date": "Nov 30, 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": "ANDA211555",
"marketing_category": "ANDA",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "20210527",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code M03BX01.
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