FDA.reportPublic FDA data

NDC 80425-0016-01 - Cyclobenzaprine HCL

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
80425-0016
Requested NDC
80425-0016-01
Package NDCs from labels
80425-0016-4, 80425-0016-2, 80425-0016-1, 80425-0016-3, 80425-0016-01
Manufacturer
Advanced Rx 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 - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0016-1Cyclobenzaprine HCL60 in 1 BOTTLETABLET, FILM COATED609
80425-0016-2Cyclobenzaprine HCL30 in 1 BOTTLETABLET, FILM COATED309
80425-0016-3Cyclobenzaprine HCL90 in 1 BOTTLETABLET, FILM COATED909
80425-0016-4Cyclobenzaprine HCL120 in 1 BOTTLETABLET, FILM COATED1209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0016CYCLOBENZAPRINE HCL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 4 package rows20250101_afca1267-4d8f-7453-e053-2995a90a865c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0016-1EA - Each80425-0016553b5f4f-98c3-412b-becd-97fa84f9445112023-03-13
80425-0016-2EA - Each80425-0016fe471193-8819-43eb-88db-2bc0724a7bd312023-03-13
80425-0016-3EA - Each80425-0016820b6eaa-987b-4e93-815e-c755aa14355b12023-03-13
80425-0016-4EA - Each80425-0016916a100b-1077-409a-8f91-67bd1ab8d97b12023-03-13

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
unii: 0VE05JYS2P
Cyclobenzaprine HCL ERCYCLOBENZAPRINE HCL ERDirect_Rxed0b9acc-132f-64c0-e053-2995a90a198c2025-01-22Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirectRxceb56ab8-4a76-6dee-e053-2995a90aab302025-01-20Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828320
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXa58cf759-048b-6740-e053-2a95a90a8b432025-01-17Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828348
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXa512d34c-8164-0c04-e053-2995a90a19422025-01-17Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.01e18825-1cf9-a98c-e063-6294a90ae0a42025-01-14Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.3dd2bde1-f06d-493a-91c7-22b28a5e16992025-01-07Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEEXELAN PHARMACEUTICALS, INC.cf81da00-7c6d-4477-bb70-b3c2abea177a2025-01-01Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx of Tennessee, LLCafca2a49-6424-7b6a-e053-2a95a90ad41e2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx of Tennessee, LLCafca1267-4d8f-7453-e053-2995a90a865c2024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA208170
ndc (package): 80425-0016-1
ndc (package): 80425-0016-4
ndc (package): 80425-0016-3
ndc (package): 80425-0016-2
ndc (product): 80425-0016
ndc11 (package): 80425001601
rxcui: 828320
spl id: 2a985779-947a-6d0e-e063-6294a90aa2a7
spl set id: afca1267-4d8f-7453-e053-2995a90a865c
unii: 0VE05JYS2P
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx of Tennessee, LLCafcab35f-4ab9-33a4-e053-2a95a90ad5292024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLCafcad582-ab59-4f70-e053-2a95a90a04e42024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx of Tennessee, LLCb062cb80-79a9-c5d8-e053-2a95a90aecfc2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 828299
unii: 0VE05JYS2P
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx Pharmacy of Tennessee, LLCc859f63a-09de-4eec-e053-2a95a90a312f2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine HCL ERCYCLOBENZAPRINE HCLAdvanced Rx Pharmacy of Tennessee, LLCf8360da5-f1d3-1d89-e053-6294a90ad31c2024-12-31Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.db49801d-9bde-5dd0-e053-2a95a90aee532024-12-26Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2998c9e6-2f60-ef35-e063-6394a90a7bc72024-12-18Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEQuality Care Products LLC794d350b-6c88-41d5-b68b-3e2c57ee2a4f2024-12-17Warnings, Adverse reactionsExact identifier
rxcui: 828299
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAmerican Health Packaging5f321a03-ccfb-4c11-ac60-a461a5580c692024-12-13Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack4c51f56b-33c3-4611-bba8-876d9dde7aff2024-11-27Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P

Reported adverse events (FAERS/openFDA)#

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