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United States · US · US:59746-177_a18ba005-b6de-4c5b-a837-489d74022084
Cyclobenzaprine Hydrochloride
Orange BookUNIISPLATC M03BX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJubilant Cadista Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM03BX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115974617706100 TABLET, FILM COATED in 1 BOTTLE (59746-177-06)
- ndc1159746177101000 TABLET, FILM COATED in 1 BOTTLE (59746-177-10)
Annotations
UNII (FDA Substance ID)
0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE
RxCUI 52101
Orange Book
A077563
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": "59746-177_a18ba005-b6de-4c5b-a837-489d74022084",
"productndc": "59746-177",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077563",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Apr 19, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Apr 19, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7.5MG",
"product_no": "003",
"approval_date": "Aug 25, 2017"
}
],
"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": "ANDA077563",
"marketing_category": "ANDA",
"nonproprietary_name": "Cyclobenzaprine Hydrochloride",
"start_marketing_date": "20060404",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03BX08.
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