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United States · US · US:63459-701_ff33280b-7ccc-4a2e-bafd-cbc89cb1cee2
AMRIX
Orange BookUNIISPLATC M03BX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCephalon, LLC
CountryUS (United States)
ATC codeM03BX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11634597016060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63459-701-60)
Annotations
UNII (FDA Substance ID)
0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE
RxCUI 52101
Orange Book
N021777
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": {
"3902123b-1365-ac3c-0934-afff9eeeb1bd": {
"match": "brand_token",
"title": "AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, LLC]",
"spl_version": "31",
"published_date": "2025-05-02"
}
},
"productid": "63459-701_ff33280b-7ccc-4a2e-bafd-cbc89cb1cee2",
"productndc": "63459-701",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "021777",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "15MG",
"product_no": "001",
"approval_date": "Feb 1, 2007"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "30MG",
"product_no": "002",
"approval_date": "Feb 1, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOBENZAPRINE HYDROCHLORIDE",
"proprietary_name": "AMRIX",
"active_ingred_unit": "mg/1",
"application_number": "NDA021777",
"marketing_category": "NDA",
"nonproprietary_name": "Cyclobenzaprine Hydrochloride",
"start_marketing_date": "20071001",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code M03BX08.
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