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United States · US · US:71335-0103_60ded7d2-5758-4bcb-9aec-928a434f3efc
Baclofen
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc117133501030120 TABLET in 1 BOTTLE (71335-0103-0)
- ndc11713350103190 TABLET in 1 BOTTLE (71335-0103-1)
- ndc11713350103220 TABLET in 1 BOTTLE (71335-0103-2)
- ndc11713350103360 TABLET in 1 BOTTLE (71335-0103-3)
- ndc11713350103445 TABLET in 1 BOTTLE (71335-0103-4)
- ndc117133501035112 TABLET in 1 BOTTLE (71335-0103-5)
- ndc11713350103630 TABLET in 1 BOTTLE (71335-0103-6)
- ndc11713350103756 TABLET in 1 BOTTLE (71335-0103-7)
- ndc11713350103815 TABLET in 1 BOTTLE (71335-0103-8)
- ndc11713350103984 TABLET in 1 BOTTLE (71335-0103-9)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A077241
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": "71335-0103_60ded7d2-5758-4bcb-9aec-928a434f3efc",
"productndc": "71335-0103",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077241",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Dec 20, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Jul 6, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "003",
"approval_date": "Sep 22, 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": "ANDA077241",
"marketing_category": "ANDA",
"nonproprietary_name": "baclofen",
"start_marketing_date": "20051220",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code M03BX01.
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