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United States · US · US:72888-145_45801dc3-fb9b-c31e-e063-6294a90aff35
BACLOFEN
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvagen Pharma Limited
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172888145361 VIAL, GLASS in 1 CARTON (72888-145-36) / 20 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A217324
APAPAP
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": "72888-145_45801dc3-fb9b-c31e-e063-6294a90aff35",
"productndc": "72888-145",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "217324",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.5MG/ML",
"product_no": "001",
"approval_date": "Feb 22, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1MG/ML",
"product_no": "002",
"approval_date": "Feb 22, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "003",
"approval_date": "Feb 22, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "BACLOFEN",
"active_ingred_unit": "ug/mL",
"application_number": "ANDA217324",
"marketing_category": "ANDA",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "20230222",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code M03BX01.
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