FDA.reportPublic FDA data

NDC 80425-0155-01 - 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
80425-0155
Requested NDC
80425-0155-01
Package NDCs from labels
80425-0155-4, 80425-0155-1, 80425-0155-3, 80425-0155-2, 80425-0155-5, 80425-0155-01
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 - 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
80425-0155-1Cyclobenzaprine HCL30 in 1 BOTTLETABLET, FILM COATED309
80425-0155-2Cyclobenzaprine HCL60 in 1 BOTTLETABLET, FILM COATED609
80425-0155-3Cyclobenzaprine HCL90 in 1 BOTTLETABLET, FILM COATED909
80425-0155-4Cyclobenzaprine HCL120 in 1 BOTTLETABLET, FILM COATED1209
80425-0155-5Cyclobenzaprine HCL180 in 1 BOTTLETABLET, FILM COATED1809

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0155CYCLOBENZAPRINE HCL TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 5 package rows20250101_c859f63a-09de-4eec-e053-2a95a90a312f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0155-1EA - Each80425-0155f4bcb5d0-e79e-475a-abc2-3f28285e790112023-03-13
80425-0155-2EA - Each80425-0155ff5212cb-fd0d-4c91-9128-b6d93df2f0a512023-03-13
80425-0155-3EA - Each80425-0155852908d7-d274-45fc-92c2-ffaa1f1c518012023-03-13
80425-0155-4EA - Each80425-0155c18b3c89-d4bf-4582-8fb2-7d8d6de5e2ad12023-03-13
80425-0155-5EA - Each80425-01553ea3d38f-4c76-4368-bd3d-7ea8652826ad12023-06-06

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 4 of 10 · 188 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLCdae3be94-a40c-5be1-e053-2a95a90a14842026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINENorthwind Health Company, LLCe04eea45-12ec-4d2b-e053-2a95a90a6b762026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLCf32bceda-1d24-322d-e053-2995a90aae1b2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLCf708cf0f-8373-14a2-e053-6394a90ab3fe2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLC1912d134-a909-5511-e063-6294a90aea292025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEMacleods Pharmaceuticals Limited1af467cb-7b21-4084-bb54-4634e928b1672025-12-26Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEGolden State Medical Supply, Inc.15c0c7aa-8c54-4040-a1bf-2a7b421ad33f2025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions81917fa4-c79c-46e2-bfbb-507fc0d7ed1b2025-12-04Warnings, Adverse reactionsExact identifier
rxcui: 828299
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.43ce2c79-ec4a-5120-e063-6394a90af6e12025-12-03Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEQPharma Incfbe6ba88-0581-50ef-e053-6394a90ab0862025-12-02Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions6b06b11c-0546-4f6e-9509-ba612bbcb9fd2025-11-19Warnings, Adverse reactionsExact identifier
application number: ANDA213324
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionsf3187074-6b55-44a3-b969-40a808eb034a2025-11-19Warnings, Adverse reactionsExact identifier
application number: ANDA213324
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionsbf3c4c2e-b089-4f83-9c6a-7ca9d9abd3ba2025-11-19Warnings, Adverse reactionsExact identifier
application number: ANDA213324
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions1cb40f47-7fbb-4537-922d-04a08dd921c52025-11-19Warnings, Adverse reactionsExact identifier
application number: ANDA213324
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEAmerican Health Packaging269bc278-963d-4830-816a-39bb4bf8c9362025-11-13Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPHOENIX RX LLC4383b26f-c39f-3d6a-e063-6294a90aba032025-11-13Warnings, Adverse reactionsExact identifier
application number: ANDA213324
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEDoc Rx4c054230-1978-44d2-9467-ed19946191132025-10-31Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAvPAK64f6d1be-4067-a5c7-2343-4aed651a0cac2025-10-28Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEAvPAKe530fd1e-06fd-0432-e053-2995a90adf5f2025-10-28Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e505c31b-4618-4e4f-8da6-92030464004f2025-10-15Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P

Reported adverse events (FAERS/openFDA)#

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