🇺🇸
United States · US · US:71335-2756_faf7a0b9-0ca6-4265-a280-b3b5f7d270b2
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
- ndc117133527560120 TABLET in 1 BOTTLE (71335-2756-0)
- ndc11713352756190 TABLET in 1 BOTTLE (71335-2756-1)
- ndc11713352756220 TABLET in 1 BOTTLE (71335-2756-2)
- ndc11713352756360 TABLET in 1 BOTTLE (71335-2756-3)
- ndc11713352756445 TABLET in 1 BOTTLE (71335-2756-4)
- ndc117133527565112 TABLET in 1 BOTTLE (71335-2756-5)
- ndc11713352756630 TABLET in 1 BOTTLE (71335-2756-6)
- ndc11713352756756 TABLET in 1 BOTTLE (71335-2756-7)
- ndc11713352756815 TABLET in 1 BOTTLE (71335-2756-8)
- ndc11713352756984 TABLET in 1 BOTTLE (71335-2756-9)
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": "71335-2756_faf7a0b9-0ca6-4265-a280-b3b5f7d270b2",
"productndc": "71335-2756",
"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": "20"
}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.