Cyclobenzaprine Hydrochloride

Product NDC
68071-2596
11-digit product format
680712596
Labeler code
68071
Product ID
68071-2596_d320189d-5c44-9cbf-e053-2a95a90a1cf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA071611
Marketing category
ANDA
Marketing start
2021-07-20
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2596-1Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2596CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20231006_d320225e-23ff-3d84-e053-2a95a90a17b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNd320225e-23ff-3d84-e053-2a95a90a17b42
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDd320225e-23ff-3d84-e053-2a95a90a17b42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2596-16807125960115 TABLET, FILM COATED in 1 BOTTLE (68071-2596-1) 2021-12-140000-00-00NoNoCurrent