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 9 of 10 · 188 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LP34ff8a08-0177-451f-9dbc-e215823461962024-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828320
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC31bb92f6-ec8c-4636-8b07-8814417fe78e2023-12-31Warnings, Adverse reactionsExact identifier
rxcui: 828320
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack4a2d3cae-5c64-4986-9707-cc213b70b7ad2023-10-19Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack85128989-bfa3-4b82-94c1-f90b14ccd2f92023-10-18Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828320
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.74af1727-e84f-4dad-82be-045e7d23beaf2023-09-06Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LP88bdee56-d6d9-4f14-be77-1e6898ba36f52023-09-01Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack6ebaccfc-f57c-4547-ade0-6a6e204f5ea02023-03-27Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.68db3c3b-8da1-4852-90b0-3172f842aa022023-03-02Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionsb524d150-0a83-42d1-a884-b930e49760cd2023-02-06Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.1adcdd8a-30f9-4a7b-853c-948a5589acab2023-01-03Warnings, Adverse reactionsExact identifier
rxcui: 828299
rxcui: 828320
rxcui: 828348
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.2a6b2ad9-307a-4976-98b7-1b96e0408da72022-09-14Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828299
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.f8dec4e2-3151-4a79-b194-a11a57ada0b62022-09-03Warnings, Adverse reactionsExact identifier
rxcui: 828299
rxcui: 828320
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESolco Healthcare U.S., LLCf558863b-ea3f-4e4b-85e9-edb2573e71512022-08-22Warnings, Adverse reactionsExact identifier
rxcui: 828320
rxcui: 828348
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.751f0d33-ceff-40b0-9329-9125f176e06a2022-07-29Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.59945ea1-8136-4014-acd9-cdfe6e11e8da2022-07-19Warnings, Adverse reactionsExact identifier
rxcui: 828299
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPe3998083-e3db-4052-9b5b-19d7aaa4e6582022-07-01Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPd8112916-28ae-452c-8ec8-a4972e5f549b2022-05-02Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPffd82a69-a64c-4399-8f5d-bddc70cdc3cf2022-05-01Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEProficient Rx LPae6de8d8-33c2-40bd-9dd3-782c879a9d8f2022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.3cdde96c-9fc9-4698-872a-25c05318ecb52021-11-19Warnings, Adverse reactionsExact identifier
rxcui: 828299
rxcui: 828320
rxcui: 828348
unii: 0VE05JYS2P

Reported adverse events (FAERS/openFDA)#

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