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United States · US · US:65862-191_13f9bb96-7677-4506-befe-d7afa9b13cab
Cyclobenzaprine Hydrochloride
Orange BookUNIISPLATC M03BX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeM03BX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116586219101100 TABLET, FILM COATED in 1 BOTTLE (65862-191-01)
- ndc116586219105500 TABLET, FILM COATED in 1 BOTTLE (65862-191-05)
- ndc1165862191991000 TABLET, FILM COATED in 1 BOTTLE (65862-191-99)
Annotations
UNII (FDA Substance ID)
0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE
RxCUI 52101
Orange Book
A078643
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": "65862-191_13f9bb96-7677-4506-befe-d7afa9b13cab",
"productndc": "65862-191",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078643",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Sep 26, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Sep 26, 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": "ANDA078643",
"marketing_category": "ANDA",
"nonproprietary_name": "Cyclobenzaprine Hydrochloride",
"start_marketing_date": "20080926",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03BX08.
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