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United States · US · US:29300-344_513de439-4155-4a5d-a25c-bced499e293a
Baclofen
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc112930034401100 TABLET in 1 BOTTLE (29300-344-01)
- ndc112930034405500 TABLET in 1 BOTTLE (29300-344-05)
- ndc1129300344101000 TABLET in 1 BOTTLE (29300-344-10)
- ndc11293003441990 TABLET in 1 BOTTLE (29300-344-19)
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": "29300-344_513de439-4155-4a5d-a25c-bced499e293a",
"productndc": "29300-344",
"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.
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