🇺🇸
United States · US · US:71335-1797_081609c5-fd3c-45d1-e063-6394a90a3e2d
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
- ndc117133517970112 TABLET in 1 BOTTLE (71335-1797-0)
- ndc11713351797130 TABLET in 1 BOTTLE (71335-1797-1)
- ndc117133517972120 TABLET in 1 BOTTLE (71335-1797-2)
- ndc11713351797320 TABLET in 1 BOTTLE (71335-1797-3)
- ndc11713351797460 TABLET in 1 BOTTLE (71335-1797-4)
- ndc117133517975100 TABLET in 1 BOTTLE (71335-1797-5)
- ndc11713351797656 TABLET in 1 BOTTLE (71335-1797-6)
- ndc11713351797790 TABLET in 1 BOTTLE (71335-1797-7)
- ndc117133517978140 TABLET in 1 BOTTLE (71335-1797-8)
- ndc11713351797984 TABLET in 1 BOTTLE (71335-1797-9)
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": "71335-1797_081609c5-fd3c-45d1-e063-6394a90a3e2d",
"productndc": "71335-1797",
"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": "20201009",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03BX01.
Access this data programmatically
Query Baclofen and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.