FDA.reportPublic FDA data

Cyclobenzaprine HCL

Product NDC
80425-0078
11-digit product format
804250078
Labeler code
80425
Product ID
80425-0078_2a9914b1-cac3-a414-e063-6394a90a6f0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA078722
Marketing category
ANDA
Marketing start
2015-03-25
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299

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
80425-0078-1Cyclobenzaprine HCL30 in 1 BOTTLETABLET, FILM COATED308
80425-0078-2Cyclobenzaprine HCL60 in 1 BOTTLETABLET, FILM COATED608
80425-0078-3Cyclobenzaprine HCL90 in 1 BOTTLETABLET, FILM COATED908
80425-0078-4Cyclobenzaprine HCL120 in 1 BOTTLETABLET, FILM COATED1208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0078-1EA - Each80425-0078faeb789a-f658-40d2-955f-90302eaac6ad12023-03-13
80425-0078-2EA - Each80425-00782ca4c93d-9118-4778-b285-ba468434b89912023-03-13
80425-0078-3EA - Each80425-0078ec0d8c5e-bb09-435d-bc04-8b71fbc307a512023-03-13
80425-0078-4EA - Each80425-00789852b7d2-cc36-43de-a98e-4ab92759605312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0078CYCLOBENZAPRINE HCL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 4 package rows20250101_b062cb80-79a9-c5d8-e053-2a95a90aecfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNb062cb80-79a9-c5d8-e053-2a95a90aecfc8
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDb062cb80-79a9-c5d8-e053-2a95a90aecfc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0078-18042500780130 TABLET, FILM COATED in 1 BOTTLE (80425-0078-1) 2015-03-250000-00-00NoNoCurrent
80425-0078-28042500780260 TABLET, FILM COATED in 1 BOTTLE (80425-0078-2) 2015-03-250000-00-00NoNoCurrent
80425-0078-38042500780390 TABLET, FILM COATED in 1 BOTTLE (80425-0078-3) 2015-03-250000-00-00NoNoCurrent
80425-0078-480425007804120 TABLET, FILM COATED in 1 BOTTLE (80425-0078-4) 2015-03-250000-00-00NoNoCurrent