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United States · US · US:71335-9638_1223f677-9ada-40f3-8eb2-aa61fe18d50a
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
- ndc117133596380112 TABLET in 1 BOTTLE (71335-9638-0)
- ndc11713359638130 TABLET in 1 BOTTLE (71335-9638-1)
- ndc117133596382120 TABLET in 1 BOTTLE (71335-9638-2)
- ndc11713359638320 TABLET in 1 BOTTLE (71335-9638-3)
- ndc11713359638460 TABLET in 1 BOTTLE (71335-9638-4)
- ndc117133596385100 TABLET in 1 BOTTLE (71335-9638-5)
- ndc11713359638656 TABLET in 1 BOTTLE (71335-9638-6)
- ndc11713359638790 TABLET in 1 BOTTLE (71335-9638-7)
- ndc117133596388140 TABLET in 1 BOTTLE (71335-9638-8)
- ndc11713359638984 TABLET in 1 BOTTLE (71335-9638-9)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A209102
ABABABAB
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": "71335-9638_1223f677-9ada-40f3-8eb2-aa61fe18d50a",
"productndc": "71335-9638",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209102",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Nov 28, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Nov 28, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "Nov 28, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "004",
"approval_date": "Feb 5, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "BACLOFEN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209102",
"marketing_category": "ANDA",
"nonproprietary_name": "BACLOFEN",
"start_marketing_date": "20180401",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03BX01.
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