Cyclobenzaprine Hydrochloride

Product NDC
71335-2156
11-digit product format
713352156
Labeler code
71335
Product ID
71335-2156_959dab21-96f5-44a0-a405-0343eeb428b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078643
Marketing category
ANDA
Marketing start
2008-09-26
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828320

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
71335-2156-0Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100105
71335-2156-1Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30105
71335-2156-2Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90105
71335-2156-3Cyclobenzaprine Hydrochloride21 in 1 BOTTLETABLET, FILM COATED21105
71335-2156-4Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED10105
71335-2156-5Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED15105
71335-2156-6Cyclobenzaprine Hydrochloride40 in 1 BOTTLETABLET, FILM COATED40105
71335-2156-7Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60105
71335-2156-8Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED20105
71335-2156-9Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED120105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2156-1EA - Each71335-215649d6a81c-7932-44df-815d-58cea0d9f01412023-01-09
71335-2156-2EA - Each71335-2156951945e9-d7da-4cd4-b1c4-0b4c032174d212023-01-09
71335-2156-5EA - Each71335-2156890f57c8-19fc-48a6-b590-e436a9ebdf9812023-01-09
71335-2156-7EA - Each71335-21565169c778-4e89-4258-b528-d81f024f969312023-01-09
71335-2156-8EA - Each71335-2156b5a6d313-1fa3-4013-97f2-d0129a63118b12023-01-09
71335-2156-9EA - Each71335-21569cf6c7e8-ce6a-4b5e-a60d-2aac5ae3b8fe12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2156CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 10 package rows20240823_0a695685-cfec-464e-840c-32e3b7a68bd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN0a695685-cfec-464e-840c-32e3b7a68bd3105
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD0a695685-cfec-464e-840c-32e3b7a68bd3105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2156-071335215600100 TABLET, FILM COATED in 1 BOTTLE (71335-2156-0) 2022-08-220000-00-00NoNoCurrent
71335-2156-17133521560130 TABLET, FILM COATED in 1 BOTTLE (71335-2156-1) 2022-08-220000-00-00NoNoCurrent
71335-2156-27133521560290 TABLET, FILM COATED in 1 BOTTLE (71335-2156-2) 2022-08-220000-00-00NoNoCurrent
71335-2156-37133521560321 TABLET, FILM COATED in 1 BOTTLE (71335-2156-3) 2022-08-220000-00-00NoNoCurrent
71335-2156-47133521560410 TABLET, FILM COATED in 1 BOTTLE (71335-2156-4) 2022-08-220000-00-00NoNoCurrent
71335-2156-57133521560515 TABLET, FILM COATED in 1 BOTTLE (71335-2156-5) 2022-08-220000-00-00NoNoCurrent
71335-2156-67133521560640 TABLET, FILM COATED in 1 BOTTLE (71335-2156-6) 2022-08-220000-00-00NoNoCurrent
71335-2156-77133521560760 TABLET, FILM COATED in 1 BOTTLE (71335-2156-7) 2022-08-220000-00-00NoNoCurrent
71335-2156-87133521560820 TABLET, FILM COATED in 1 BOTTLE (71335-2156-8) 2022-08-220000-00-00NoNoCurrent
71335-2156-971335215609120 TABLET, FILM COATED in 1 BOTTLE (71335-2156-9) 2022-08-220000-00-00NoNoCurrent