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United States · US · US:42571-429_0acb9150-3e4c-9f37-e063-6294a90a7fd6
Baclofen
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114257142901100 TABLET in 1 BOTTLE (42571-429-01)
- ndc114257142905500 TABLET in 1 BOTTLE (42571-429-05)
- ndc1142571429131000 TABLET in 1 BOTTLE (42571-429-13)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A217687
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": "42571-429_0acb9150-3e4c-9f37-e063-6294a90a7fd6",
"productndc": "42571-429",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "217687",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Nov 8, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Nov 8, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "Nov 8, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "Baclofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217687",
"marketing_category": "ANDA",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "20240401",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code M03BX01.
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