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United States · US · US:71335-9759_6e78ab9d-0fb9-449a-81ed-a2f9324601ed
BACLOFEN
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc117133597590112 TABLET in 1 BOTTLE (71335-9759-0)
- ndc11713359759130 TABLET in 1 BOTTLE (71335-9759-1)
- ndc117133597592120 TABLET in 1 BOTTLE (71335-9759-2)
- ndc11713359759320 TABLET in 1 BOTTLE (71335-9759-3)
- ndc11713359759460 TABLET in 1 BOTTLE (71335-9759-4)
- ndc117133597595100 TABLET in 1 BOTTLE (71335-9759-5)
- ndc11713359759656 TABLET in 1 BOTTLE (71335-9759-6)
- ndc11713359759790 TABLET in 1 BOTTLE (71335-9759-7)
- ndc117133597598140 TABLET in 1 BOTTLE (71335-9759-8)
- ndc11713359759984 TABLET in 1 BOTTLE (71335-9759-9)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A214374
ABABAB
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": "ORAL",
"spl_meta": {
"e017a001-8cb1-4dd8-960e-c6d74005f57f": {
"match": "brand_token",
"title": "BACLOFEN TABLET [REMEDYREPACK INC.]",
"spl_version": "1",
"published_date": "2026-05-13"
}
},
"productid": "71335-9759_6e78ab9d-0fb9-449a-81ed-a2f9324601ed",
"productndc": "71335-9759",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214374",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Mar 5, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Mar 5, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "Mar 5, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "BACLOFEN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214374",
"marketing_category": "ANDA",
"nonproprietary_name": "BACLOFEN",
"start_marketing_date": "20210701",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03BX01.
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