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United States · US · US:25021-681_570e9773-fda9-492f-bdef-7dd6814fd3b2
Baclofen
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1125021681712 SYRINGE in 1 CARTON (25021-681-71) / 1 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A210777
AP
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": "25021-681_570e9773-fda9-492f-bdef-7dd6814fd3b2",
"productndc": "25021-681",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "210777",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.05MG/ML",
"product_no": "001",
"approval_date": "Jan 15, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "Baclofen",
"active_ingred_unit": "ug/mL",
"application_number": "ANDA210777",
"marketing_category": "ANDA",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "20210715",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code M03BX01.
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