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United States · US · US:76282-283_19cb705f-c529-4ad4-8eda-3a3fd48feca7
Cyclobenzaprine Hydrochloride
Orange BookUNIISPLATC M03BX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEXELAN PHARMACEUTICALS, INC.
CountryUS (United States)
ATC codeM03BX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc1176282283101000 TABLET in 1 BOTTLE (76282-283-10)
- ndc117628228318180 TABLET in 1 BOTTLE (76282-283-18)
- ndc117628228327270 TABLET in 1 BOTTLE (76282-283-27)
- ndc11762822833030 TABLET in 1 BOTTLE (76282-283-30)
- ndc11762822836060 TABLET in 1 BOTTLE (76282-283-60)
- ndc11762822839090 TABLET in 1 BOTTLE (76282-283-90)
Annotations
UNII (FDA Substance ID)
0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE
RxCUI 52101
Orange Book
A090478
ABAB
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": "76282-283_19cb705f-c529-4ad4-8eda-3a3fd48feca7",
"productndc": "76282-283",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090478",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jul 23, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Jul 23, 2010"
}
],
"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": "ANDA090478",
"marketing_category": "ANDA",
"nonproprietary_name": "Cyclobenzaprine",
"start_marketing_date": "20250410",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03BX08.
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