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United States · US · US:66794-156_5135dfce-e3c4-a382-e063-6394a90a4875
Gablofen
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPiramal Critical Care Inc
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11667941560120 mL in 1 SYRINGE, GLASS (66794-156-01)
- ndc11667941560220 mL in 1 VIAL, GLASS (66794-156-02)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
N022462
APAPAPAP
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": {
"00d3e846-dd92-448d-9ab8-6a07be823cc1": {
"match": "brand_token",
"title": "GABLOFEN (BACLOFEN INJECTION) INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC]",
"spl_version": "43",
"published_date": "2026-05-20"
}
},
"productid": "66794-156_5135dfce-e3c4-a382-e063-6394a90a4875",
"productndc": "66794-156",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "022462",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "0.05MG/ML",
"product_no": "001",
"approval_date": "Nov 19, 2010"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "0.5MG/ML",
"product_no": "002",
"approval_date": "Nov 19, 2010"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "003",
"approval_date": "Nov 19, 2010"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "1MG/ML",
"product_no": "004",
"approval_date": "Jun 22, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "Gablofen",
"active_ingred_unit": "ug/mL",
"application_number": "NDA022462",
"marketing_category": "NDA",
"nonproprietary_name": "Baclofen Injection",
"start_marketing_date": "20170401",
"active_numerator_strength": "1000"
}Related drugs
Other records sharing ATC code M03BX01.
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