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United States · US · US:80425-0155_2a99a7c1-c4c1-2b01-e063-6294a90aa3b8
Cyclobenzaprine HCL
Orange BookUNIISPLATC M03BX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeM03BX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11804250155130 TABLET, FILM COATED in 1 BOTTLE (80425-0155-1)
- ndc11804250155260 TABLET, FILM COATED in 1 BOTTLE (80425-0155-2)
- ndc11804250155390 TABLET, FILM COATED in 1 BOTTLE (80425-0155-3)
- ndc118042501554120 TABLET, FILM COATED in 1 BOTTLE (80425-0155-4)
- ndc118042501555180 TABLET, FILM COATED in 1 BOTTLE (80425-0155-5)
Annotations
UNII (FDA Substance ID)
0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE
RxCUI 52101
Orange Book
A213324
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": "80425-0155_2a99a7c1-c4c1-2b01-e063-6294a90aa3b8",
"productndc": "80425-0155",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213324",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jul 6, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7.5MG",
"product_no": "002",
"approval_date": "Jul 6, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "003",
"approval_date": "Jul 5, 2020"
}
],
"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": "ANDA213324",
"marketing_category": "ANDA",
"nonproprietary_name": "Cyclobenzaprine HCL",
"start_marketing_date": "20200706",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M03BX08.
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