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United States · US · US:55289-757_419b4e87-cb86-8fbc-e063-6394a90a3b7c
Baclofen
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11552897573030 TABLET in 1 BOTTLE, PLASTIC (55289-757-30)
- ndc11552897576060 TABLET in 1 BOTTLE, PLASTIC (55289-757-60)
- ndc11552897579090 TABLET in 1 BOTTLE, PLASTIC (55289-757-90)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A072234
AB
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": "55289-757_419b4e87-cb86-8fbc-e063-6394a90a3b7c",
"productndc": "55289-757",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "072234",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jul 21, 1988"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "Baclofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA072234",
"marketing_category": "ANDA",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "19880721",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03BX01.
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