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United States · US · US:68788-8221_b81515f8-f4d3-4e71-82d0-830652940588
Cyclobenzaprine Hydrochloride
Orange BookUNIISPLATC M03BX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM03BX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11687888221220 TABLET, FILM COATED in 1 BOTTLE (68788-8221-2)
- ndc11687888221330 TABLET, FILM COATED in 1 BOTTLE (68788-8221-3)
- ndc11687888221660 TABLET, FILM COATED in 1 BOTTLE (68788-8221-6)
- ndc116878882218120 TABLET, FILM COATED in 1 BOTTLE (68788-8221-8)
- ndc11687888221990 TABLET, FILM COATED in 1 BOTTLE (68788-8221-9)
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": "68788-8221_b81515f8-f4d3-4e71-82d0-830652940588",
"productndc": "68788-8221",
"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": "20220909",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M03BX08.
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