FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
0904-7400
11-digit product format
009047400
Labeler code
0904
Product ID
0904-7400_01d0daef-106b-4557-95d2-380a993ba9f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078643
Marketing category
ANDA
Marketing start
2008-09-26
Marketing end
2027-01-31
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE5 mg/1

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
0904-7400-04Cyclobenzaprine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED13
0904-7400-04Cyclobenzaprine Hydrochloride30 in 1 CARTONTABLET, FILM COATED303
0904-7400-06Cyclobenzaprine Hydrochloride50 in 1 CARTONTABLET, FILM COATED503
0904-7400-06Cyclobenzaprine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7400-04EA - Each0904-74000dbda2d4-24b4-4b8c-8bf8-6a9c619ad06212024-05-16
0904-7400-06EA - Each0904-7400d7705694-5f3d-472b-b109-7d87fc94589912024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7400CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1Current NDC, 4 package rows20240224_508e310e-067a-4f95-869a-e1da49aabe94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN508e310e-067a-4f95-869a-e1da49aabe943
828320cyclobenzaprine HCl 5 MG Oral TabletPSN508e310e-067a-4f95-869a-e1da49aabe943
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD508e310e-067a-4f95-869a-e1da49aabe943
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD508e310e-067a-4f95-869a-e1da49aabe943

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7400-040090474000430 BLISTER PACK in 1 CARTON (0904-7400-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2024-02-212027-01-31NoNoHistorical
0904-7400-060090474000650 BLISTER PACK in 1 CARTON (0904-7400-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2024-02-212027-01-31NoNoHistorical