🇺🇸
United States · US · US:80425-0016_2a985779-947a-6d0e-e063-6294a90aa2a7
Cyclobenzaprine HCL
Orange BookUNIISPLATC M03BX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeM03BX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11804250016160 TABLET, FILM COATED in 1 BOTTLE (80425-0016-1)
- ndc11804250016230 TABLET, FILM COATED in 1 BOTTLE (80425-0016-2)
- ndc11804250016390 TABLET, FILM COATED in 1 BOTTLE (80425-0016-3)
- ndc118042500164120 TABLET, FILM COATED in 1 BOTTLE (80425-0016-4)
Annotations
UNII (FDA Substance ID)
0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE
RxCUI 52101
Orange Book
A208170
ABABAB
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": "80425-0016_2a985779-947a-6d0e-e063-6294a90aa2a7",
"productndc": "80425-0016",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208170",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "May 31, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7.5MG",
"product_no": "002",
"approval_date": "May 31, 2017"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "003",
"approval_date": "May 31, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOBENZAPRINE HYDROCHLORIDE",
"proprietary_name": "Cyclobenzaprine HCL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208170",
"marketing_category": "ANDA",
"nonproprietary_name": "Cyclobenzaprine HCL",
"start_marketing_date": "20170531",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M03BX08.
Access this data programmatically
Query Cyclobenzaprine HCL 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.