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 5 of 10 · 188 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack8a8c9479-b3ab-453a-bd8a-deaf380007422025-09-24Warnings, Adverse reactionsExact identifier
application number: NDA021777
rxcui: 828353
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackcc93038f-1202-47f3-a959-2877877cc8692025-09-11Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEDoc Rxd4457b8c-fff8-4c19-8d5a-a667161e54462025-09-04Warnings, Adverse reactionsExact identifier
application number: NDA021777
rxcui: 828358
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionseb908b77-741c-473a-b2e9-4f82167c30882025-08-26Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions4923ac1f-d463-465b-9e99-7312aef878612025-08-26Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionsd6448bb1-9b8d-45f4-a14b-8328248e586e2025-08-26Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC3bddfe25-00ba-747f-e063-6394a90a9ce62025-08-08Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEAphena Pharma Solutions - Tennessee, LLC3bc7e2b4-e1a0-66e3-e063-6294a90a676a2025-08-07Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.820dca15-5b7f-41e0-955f-73f9427092642025-08-01Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESOLA Pharmaceuticals, LLCdb930d05-3f92-41f1-888c-301b2c4565e62025-07-30Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAvKAREa264ab9f-cc12-325f-e053-2a95a90a53d92025-07-24Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEPHOENIX RX LLC3a90171b-aef3-0691-e063-6294a90a65602025-07-22Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPHOENIX RX LLC3a116427-c427-c3bc-e063-6294a90ac5392025-07-21Warnings, Adverse reactionsExact identifier
application number: NDA021777
rxcui: 828358
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack6536b470-9a4e-4174-85b8-479f64cc32962025-07-14Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.e3b5fc92-9186-6944-e053-2a95a90a1c9f2025-07-08Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDECoupler LLC37c8c0d6-98c0-c1a5-e063-6394a90a79312025-06-17Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC34f4e63a-1259-0226-e063-6294a90a9fc42025-06-16Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCdd546a0e-e5be-4232-8ad8-fcd7d5f9a9032025-05-27Warnings, Adverse reactionsExact identifier
application number: NDA021777
ndc (product): 0115-1436
rxcui: 828358
rxcui: 828353
spl id: 8e7da23f-dda8-4834-91ae-0691668d1374
spl set id: dd546a0e-e5be-4232-8ad8-fcd7d5f9a903
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.59b428fa-5013-4b2b-872f-16ba4a9d4f5d2025-05-01Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9161cb5e-63e5-41d7-9bde-66c7b7b7a2f32025-05-01Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P

Reported adverse events (FAERS/openFDA)#

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