🇺🇸
United States · US · US:71335-0949_b1a443f7-54c7-4f66-9389-9bcbf7abcd62
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
- ndc117133509490120 TABLET in 1 BOTTLE (71335-0949-0)
- ndc11713350949190 TABLET in 1 BOTTLE (71335-0949-1)
- ndc11713350949220 TABLET in 1 BOTTLE (71335-0949-2)
- ndc11713350949360 TABLET in 1 BOTTLE (71335-0949-3)
- ndc11713350949445 TABLET in 1 BOTTLE (71335-0949-4)
- ndc117133509495112 TABLET in 1 BOTTLE (71335-0949-5)
- ndc11713350949630 TABLET in 1 BOTTLE (71335-0949-6)
- ndc11713350949756 TABLET in 1 BOTTLE (71335-0949-7)
- ndc11713350949815 TABLET in 1 BOTTLE (71335-0949-8)
- ndc11713350949984 TABLET in 1 BOTTLE (71335-0949-9)
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": "71335-0949_b1a443f7-54c7-4f66-9389-9bcbf7abcd62",
"productndc": "71335-0949",
"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": "20"
}Related drugs
Other records sharing ATC code M03BX01.
Access this data programmatically
Query BACLOFEN and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.