Cyclobenzaprine Hydrochloride

Product NDC
68071-2673
11-digit product format
680712673
Labeler code
68071
Product ID
68071-2673_e3b4284c-8653-5ee4-e053-2995a90a082e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078643
Marketing category
ANDA
Marketing start
2008-09-26
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
68071-2673-4Cyclobenzaprine Hydrochloride4 in 1 BOTTLETABLET, FILM COATED42
68071-2673-6Cyclobenzaprine Hydrochloride6 in 1 BOTTLETABLET, FILM COATED62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2673CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20220715_dd7d56f0-bed5-21c3-e053-2a95a90a746f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNdd7d56f0-bed5-21c3-e053-2a95a90a746f2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDdd7d56f0-bed5-21c3-e053-2a95a90a746f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2673-4680712673044 TABLET, FILM COATED in 1 BOTTLE (68071-2673-4) 2022-04-250000-00-00NoNoCurrent
68071-2673-6680712673066 TABLET, FILM COATED in 1 BOTTLE (68071-2673-6) 2022-04-250000-00-00NoNoCurrent