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United States · US · US:68071-3567_11d3bbb6-f6bd-0193-e063-6294a90a6957
Cyclobenzaprine hydrochloride
Orange BookUNIISPLATC M03BX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeM03BX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11680713567212 TABLET, FILM COATED in 1 BOTTLE (68071-3567-2)
- ndc11680713567330 TABLET, FILM COATED in 1 BOTTLE (68071-3567-3)
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": "68071-3567_11d3bbb6-f6bd-0193-e063-6294a90a6957",
"productndc": "68071-3567",
"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 hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213324",
"marketing_category": "ANDA",
"nonproprietary_name": "Cyclobenzaprine hydrochloride",
"start_marketing_date": "20200706",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M03BX08.
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