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United States · US · US:50090-1848_1152b0be-6787-461b-bf78-695595c2c63b
Cyclobenzaprine Hydrochloride
Orange BookUNIISPLATC M03BX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeM03BX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11500901848015 TABLET, FILM COATED in 1 BOTTLE (50090-1848-0)
- ndc11500901848130 TABLET, FILM COATED in 1 BOTTLE (50090-1848-1)
- ndc11500901848260 TABLET, FILM COATED in 1 BOTTLE (50090-1848-2)
Annotations
UNII (FDA Substance ID)
0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE
RxCUI 52101
Orange Book
A078722
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0VE05JYS2P",
"rxcui": "52101",
"inchikey": "VXEAYBOGHINOKW-UHFFFAOYSA-N",
"display_name": "CYCLOBENZAPRINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fe81c68d-a579-4fe9-e053-6294a90a7bc0": {
"match": "brand_token",
"title": "CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]",
"spl_version": "8",
"published_date": "2026-06-01"
}
},
"productid": "50090-1848_1152b0be-6787-461b-bf78-695595c2c63b",
"productndc": "50090-1848",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078722",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "May 12, 2008"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "7.5MG",
"product_no": "002",
"approval_date": "May 12, 2008"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "003",
"approval_date": "May 12, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOBENZAPRINE HYDROCHLORIDE",
"proprietary_name": "Cyclobenzaprine Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078722",
"marketing_category": "ANDA",
"nonproprietary_name": "Cyclobenzaprine Hydrochloride",
"start_marketing_date": "20150325",
"active_numerator_strength": "7.5"
}Related drugs
Other records sharing ATC code M03BX08.
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