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United States · US · US:70511-124_c15b60c7-4e21-4e28-898c-31e23052737a
Baclofen (Intrathecal)
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMAIA Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170511124101 VIAL in 1 CARTON (70511-124-10) / 20 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A210048
APAP
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": "INTRATHECAL",
"spl_meta": {
"e017a001-8cb1-4dd8-960e-c6d74005f57f": {
"match": "brand_token",
"title": "BACLOFEN TABLET [REMEDYREPACK INC.]",
"spl_version": "1",
"published_date": "2026-05-13"
}
},
"productid": "70511-124_c15b60c7-4e21-4e28-898c-31e23052737a",
"productndc": "70511-124",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "210048",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.5MG/ML",
"product_no": "001",
"approval_date": "Sep 11, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "002",
"approval_date": "Sep 11, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "Baclofen (Intrathecal)",
"active_ingred_unit": "ug/mL",
"application_number": "ANDA210048",
"marketing_category": "ANDA",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "20190925",
"active_numerator_strength": "2000"
}Related drugs
Other records sharing ATC code M03BX01.
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