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United States · US · US:70121-2501_d68a08e0-d0d9-4144-be01-47b636dfa7e1
Lioresal (baclofen)
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170121250111 AMPULE in 1 BOX (70121-2501-1) / 1 KIT in 1 AMPULE
Annotations
Orange Book
N020075
APAPAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "INTRATHECAL",
"spl_meta": {
"6f3bdcc0-ffc8-4911-8c35-958c8103a2c5": {
"match": "brand_token",
"title": "LIORESAL (BACLOFEN) (BACLOFEN) KIT LIORESAL (BACLOFEN) (BACLOFEN) INJECTION [AMNEAL PHARMACEUTICALS LLC]",
"spl_version": "29",
"published_date": "2025-11-18"
}
},
"productid": "70121-2501_d68a08e0-d0d9-4144-be01-47b636dfa7e1",
"productndc": "70121-2501",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "020075",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "0.5MG/ML",
"product_no": "001",
"approval_date": "Jun 17, 1992"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "002",
"approval_date": "Jun 17, 1992"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "0.05MG/ML",
"product_no": "003",
"approval_date": "Nov 7, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Lioresal (baclofen)",
"active_ingred_unit": null,
"application_number": "NDA020075",
"marketing_category": "NDA",
"nonproprietary_name": "baclofen",
"start_marketing_date": "20220612",
"active_numerator_strength": null
}Access this data programmatically
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