🇺🇸
United States · US · US:68134-403_47426f2f-4630-5a83-e063-6294a90a88d1
Baclofen
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPalmetto Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116813440316473 mL in 1 BOTTLE (68134-403-16)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
N208193
AA
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": "68134-403_47426f2f-4630-5a83-e063-6294a90a88d1",
"productndc": "68134-403",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "208193",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Sep 18, 2019"
},
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "10MG/5ML",
"product_no": "002",
"approval_date": "Oct 12, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "Baclofen",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA208193",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "20240925",
"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.