FDA.reportPublic FDA data

NDC 80425-0292-01 - Cyclobenzaprine HCL ER

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0292
Requested NDC
80425-0292-01
Package NDCs from labels
80425-0292-1, 80425-0292-2, 80425-0292-3, 80425-0292-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyclobenzaprine HCL ER - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0292-1Cyclobenzaprine HCLER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
80425-0292-2Cyclobenzaprine HCLER60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
80425-0292-3Cyclobenzaprine HCLER90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0292CYCLOBENZAPRINE HCL ER (CYCLOBENZAPRINE HCL) CAPSULE, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8360da5-f1d3-1d89-e053-6294a90ad31c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0292-1EA - Each80425-02922e44b7d0-6868-4599-90e1-24ed3e9d2e0d12023-06-06
80425-0292-2EA - Each80425-0292b9d25f7c-b567-4941-b32c-9b6c1772fcda12023-06-06
80425-0292-3EA - Each80425-02926480d838-8c92-4e23-8982-918a017f2b7c12023-06-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 10 · 188 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HCL ERCYCLOBENZAPRINE HCL ERDirect_Rxe4a3383a-7b30-25b7-e053-2995a90a341b2025-01-22Warnings, Adverse reactionsExact identifier
application number: NDA021777
rxcui: 828358
unii: 0VE05JYS2P
Cyclobenzaprine HCL ERCYCLOBENZAPRINE HCL ERDirect_Rxed0b9acc-132f-64c0-e053-2995a90a198c2025-01-22Warnings, Adverse reactionsExact identifier
application number: NDA021777
rxcui: 828358
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirectRxceb56ab8-4a76-6dee-e053-2995a90aab302025-01-20Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXa58cf759-048b-6740-e053-2a95a90a8b432025-01-17Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXa512d34c-8164-0c04-e053-2995a90a19422025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 828358
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.01e18825-1cf9-a98c-e063-6294a90ae0a42025-01-14Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.3dd2bde1-f06d-493a-91c7-22b28a5e16992025-01-07Warnings, Adverse reactionsExact identifier
rxcui: 828358
rxcui: 828353
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEEXELAN PHARMACEUTICALS, INC.cf81da00-7c6d-4477-bb70-b3c2abea177a2025-01-01Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx of Tennessee, LLCafca2a49-6424-7b6a-e053-2a95a90ad41e2024-12-31Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx of Tennessee, LLCafca1267-4d8f-7453-e053-2995a90a865c2024-12-31Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx of Tennessee, LLCafcab35f-4ab9-33a4-e053-2a95a90ad5292024-12-31Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLCafcad582-ab59-4f70-e053-2a95a90a04e42024-12-31Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx of Tennessee, LLCb062cb80-79a9-c5d8-e053-2a95a90aecfc2024-12-31Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx Pharmacy of Tennessee, LLCc859f63a-09de-4eec-e053-2a95a90a312f2024-12-31Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HCL ERCYCLOBENZAPRINE HCLAdvanced Rx Pharmacy of Tennessee, LLCf8360da5-f1d3-1d89-e053-6294a90ad31c2024-12-31Warnings, Adverse reactionsExact identifier
application number: NDA021777
ndc (package): 80425-0292-1
ndc (package): 80425-0292-3
ndc (package): 80425-0292-2
ndc (product): 80425-0292
ndc11 (package): 80425029201
rxcui: 828358
spl id: 2a9bfe6a-6d67-b262-e063-6294a90a1cf3
spl set id: f8360da5-f1d3-1d89-e053-6294a90ad31c
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.db49801d-9bde-5dd0-e053-2a95a90aee532024-12-26Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2998c9e6-2f60-ef35-e063-6394a90a7bc72024-12-18Warnings, Adverse reactionsExact identifier
rxcui: 828358
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEQuality Care Products LLC794d350b-6c88-41d5-b68b-3e2c57ee2a4f2024-12-17Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAmerican Health Packaging5f321a03-ccfb-4c11-ac60-a461a5580c692024-12-13Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack4c51f56b-33c3-4611-bba8-876d9dde7aff2024-11-27Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.