FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
68071-4935
11-digit product format
680714935
Labeler code
68071
Product ID
68071-4935_1ae26a9a-3bd7-c2fc-e063-6294a90a89bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828348

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4935-62024-06-14C16284748780-1ba0f9c33-276d-a910-e053-dadaa90a0b85Cyclobenzaprine hydrochloride, USP
68071-4935-62023-01-30C16284748780-1ba0f9c33-276d-a910-e053-dadaa90a0b85Cyclobenzaprine hydrochloride, USP
68071-4935-62021-02-18C16284748780-1ba0f9c33-276d-a910-e053-dadaa90a0b85Cyclobenzaprine hydrochloride, USP
68071-4935-62021-01-29C16284748780-1ba0f9c33-276d-a910-e053-dadaa90a0b85Cyclobenzaprine hydrochloride, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4935-6CYCLOBENZAPRINE HYDROCHLORIDE6 in 1 BOTTLETABLET, FILM COATED63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4935CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240616_8bdc725e-22e3-0f32-e053-2a95a90ae8a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN8bdc725e-22e3-0f32-e053-2a95a90ae8a93
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD8bdc725e-22e3-0f32-e053-2a95a90ae8a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4935-6680714935066 TABLET, FILM COATED in 1 BOTTLE (68071-4935-6) 2019-06-210000-00-00NoNoCurrent