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United States · US · US:71335-9681_b63760e4-d4d2-47a9-ac83-a08352a16435
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
- ndc117133596810120 TABLET in 1 BOTTLE, PLASTIC (71335-9681-0)
- ndc11713359681190 TABLET in 1 BOTTLE, PLASTIC (71335-9681-1)
- ndc11713359681220 TABLET in 1 BOTTLE, PLASTIC (71335-9681-2)
- ndc11713359681360 TABLET in 1 BOTTLE, PLASTIC (71335-9681-3)
- ndc11713359681445 TABLET in 1 BOTTLE, PLASTIC (71335-9681-4)
- ndc117133596815112 TABLET in 1 BOTTLE, PLASTIC (71335-9681-5)
- ndc11713359681630 TABLET in 1 BOTTLE, PLASTIC (71335-9681-6)
- ndc11713359681756 TABLET in 1 BOTTLE, PLASTIC (71335-9681-7)
- ndc11713359681815 TABLET in 1 BOTTLE, PLASTIC (71335-9681-8)
- ndc11713359681984 TABLET in 1 BOTTLE, PLASTIC (71335-9681-9)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A077068
ABAB
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": "71335-9681_b63760e4-d4d2-47a9-ac83-a08352a16435",
"productndc": "71335-9681",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077068",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Aug 30, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Aug 30, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "Baclofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077068",
"marketing_category": "ANDA",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "20050830",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code M03BX01.
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