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United States · US · US:71335-2767_5bae76d2-2bf4-4353-ac07-0156403a7cf1
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
- ndc117133527670112 TABLET in 1 BLISTER PACK (71335-2767-0)
- ndc11713352767130 TABLET in 1 BLISTER PACK (71335-2767-1)
- ndc117133527672120 TABLET in 1 BLISTER PACK (71335-2767-2)
- ndc11713352767320 TABLET in 1 BLISTER PACK (71335-2767-3)
- ndc11713352767460 TABLET in 1 BLISTER PACK (71335-2767-4)
- ndc117133527675100 TABLET in 1 BLISTER PACK (71335-2767-5)
- ndc11713352767656 TABLET in 1 BLISTER PACK (71335-2767-6)
- ndc11713352767790 TABLET in 1 BLISTER PACK (71335-2767-7)
- ndc117133527678140 TABLET in 1 BLISTER PACK (71335-2767-8)
- ndc11713352767984 TABLET in 1 BLISTER PACK (71335-2767-9)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A212378
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": "71335-2767_5bae76d2-2bf4-4353-ac07-0156403a7cf1",
"productndc": "71335-2767",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212378",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Oct 9, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Oct 9, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "003",
"approval_date": "Apr 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": "ANDA212378",
"marketing_category": "ANDA",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "20240615",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03BX01.
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