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United States · US · US:0527-1337_153f6bd7-9462-4d92-b738-48e7807c5919
Baclofen
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc110527133701100 TABLET in 1 BOTTLE, PLASTIC (0527-1337-01)
- ndc110527133705500 TABLET in 1 BOTTLE, PLASTIC (0527-1337-05)
- ndc1105271337101000 TABLET in 1 BOTTLE, PLASTIC (0527-1337-10)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A077241
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": "0527-1337_153f6bd7-9462-4d92-b738-48e7807c5919",
"productndc": "0527-1337",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077241",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Dec 20, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Jul 6, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "003",
"approval_date": "Sep 22, 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": "ANDA077241",
"marketing_category": "ANDA",
"nonproprietary_name": "baclofen",
"start_marketing_date": "20051220",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code M03BX01.
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