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United States · US · US:71335-2392_a8fc5ccd-16f4-4cb1-a422-f49efddf6adb
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
- ndc117133523920112 TABLET in 1 BOTTLE (71335-2392-0)
- ndc11713352392130 TABLET in 1 BOTTLE (71335-2392-1)
- ndc117133523922120 TABLET in 1 BOTTLE (71335-2392-2)
- ndc11713352392320 TABLET in 1 BOTTLE (71335-2392-3)
- ndc11713352392460 TABLET in 1 BOTTLE (71335-2392-4)
- ndc117133523925100 TABLET in 1 BOTTLE (71335-2392-5)
- ndc11713352392656 TABLET in 1 BOTTLE (71335-2392-6)
- ndc11713352392790 TABLET in 1 BOTTLE (71335-2392-7)
- ndc117133523928140 TABLET in 1 BOTTLE (71335-2392-8)
- ndc11713352392984 TABLET in 1 BOTTLE (71335-2392-9)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A212067
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": "71335-2392_a8fc5ccd-16f4-4cb1-a422-f49efddf6adb",
"productndc": "71335-2392",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212067",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jul 9, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Jul 9, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "003",
"approval_date": "Mar 9, 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": "ANDA212067",
"marketing_category": "ANDA",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "20200709",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03BX01.
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