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United States · US · US:71335-1356_018c5e52-baa0-4aff-a1ff-604cc1bf20a9
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
- ndc117133513560120 TABLET in 1 BOTTLE (71335-1356-0)
- ndc11713351356190 TABLET in 1 BOTTLE (71335-1356-1)
- ndc11713351356220 TABLET in 1 BOTTLE (71335-1356-2)
- ndc11713351356360 TABLET in 1 BOTTLE (71335-1356-3)
- ndc11713351356445 TABLET in 1 BOTTLE (71335-1356-4)
- ndc117133513565112 TABLET in 1 BOTTLE (71335-1356-5)
- ndc11713351356630 TABLET in 1 BOTTLE (71335-1356-6)
- ndc11713351356756 TABLET in 1 BOTTLE (71335-1356-7)
- ndc11713351356815 TABLET in 1 BOTTLE (71335-1356-8)
- ndc11713351356984 TABLET in 1 BOTTLE (71335-1356-9)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A211659
ABABABAB
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": "71335-1356_018c5e52-baa0-4aff-a1ff-604cc1bf20a9",
"productndc": "71335-1356",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211659",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Nov 23, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Nov 23, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "003",
"approval_date": "Apr 17, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "004",
"approval_date": "Feb 13, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "Baclofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211659",
"marketing_category": "ANDA",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "20181206",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code M03BX01.
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