FDA.reportPublic FDA data

Cyclobenzaprine HCL

Product NDC
80425-0155
11-digit product format
804250155
Labeler code
80425
Product ID
80425-0155_2a99a7c1-c4c1-2b01-e063-6294a90aa3b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA213324
Marketing category
ANDA
Marketing start
2020-07-06
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828320

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNc859f63a-09de-4eec-e053-2a95a90a312f9
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDc859f63a-09de-4eec-e053-2a95a90a312f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0155-18042501550130 TABLET, FILM COATED in 1 BOTTLE (80425-0155-1) 2023-03-30NoNoCurrent
80425-0155-28042501550260 TABLET, FILM COATED in 1 BOTTLE (80425-0155-2) 2023-03-30NoNoCurrent
80425-0155-38042501550390 TABLET, FILM COATED in 1 BOTTLE (80425-0155-3) 2023-03-30NoNoCurrent
80425-0155-480425015504120 TABLET, FILM COATED in 1 BOTTLE (80425-0155-4) 2023-03-30NoNoCurrent
80425-0155-580425015505180 TABLET, FILM COATED in 1 BOTTLE (80425-0155-5) 2023-03-30NoNoCurrent