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United States · US · US:76420-896_2b1fe790-9c6e-85ed-e063-6294a90a6471
Cyclobenzaprine Hydrochloride
Orange BookUNIISPLATC M03BX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeM03BX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc117642089601100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-896-01)
- ndc11764208963030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-896-30)
- ndc11764208966060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-896-60)
- ndc11764208969090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-896-90)
Annotations
UNII (FDA Substance ID)
0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE
RxCUI 52101
Orange Book
A091281
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": "76420-896_2b1fe790-9c6e-85ed-e063-6294a90a6471",
"productndc": "76420-896",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "091281",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "001",
"approval_date": "Jan 31, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "002",
"approval_date": "Jan 31, 2013"
}
],
"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": "ANDA091281",
"marketing_category": "ANDA",
"nonproprietary_name": "Cyclobenzaprine Hydrochloride",
"start_marketing_date": "20190301",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code M03BX08.
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