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United States · US · US:69528-302_4ce95252-8c9b-2246-e063-6294a90a8b25
OZOBAX
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRosemont Pharmaceuticals LLC
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116952830208237 mL in 1 BOTTLE (69528-302-08)
- ndc116952830216473 mL in 1 BOTTLE (69528-302-16)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
N208193
AA
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": {
"d8ddcec5-debe-42b4-a803-e65917cc6a54": {
"match": "brand_token",
"title": "OZOBAX DS (BACLOFEN) SOLUTION [ROSEMONT PHARMACEUTICALS LLC]",
"spl_version": "2",
"published_date": "2026-03-26"
}
},
"productid": "69528-302_4ce95252-8c9b-2246-e063-6294a90a8b25",
"productndc": "69528-302",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "208193",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Sep 18, 2019"
},
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "10MG/5ML",
"product_no": "002",
"approval_date": "Oct 12, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "OZOBAX",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA208193",
"marketing_category": "NDA",
"nonproprietary_name": "Baclofen",
"start_marketing_date": "20231012",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03BX01.
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