Cyclobenzaprine Hydrochloride

Product NDC
71205-201
11-digit product format
712050201
Labeler code
71205
Product ID
71205-201_9143ab9f-5bc2-4ea6-a33b-01bbc1e880f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077797
Marketing category
ANDA
Marketing start
2017-03-30
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-201-10Cyclobenzaprine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED102
71205-201-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED152
71205-201-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
71205-201-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
71205-201-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
71205-201-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-201CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20191012_571fbb2b-24e0-4de3-8cfa-c267fc397b6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN571fbb2b-24e0-4de3-8cfa-c267fc397b6c2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD571fbb2b-24e0-4de3-8cfa-c267fc397b6c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-201-107120502011010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-10) 2019-01-010000-00-00NoNoCurrent
71205-201-157120502011515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-15) 2019-01-010000-00-00NoNoCurrent
71205-201-207120502012020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-20) 2019-01-010000-00-00NoNoCurrent
71205-201-307120502013030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-30) 2019-01-010000-00-00NoNoCurrent
71205-201-607120502016060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-60) 2019-01-010000-00-00NoNoCurrent
71205-201-907120502019090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-90) 2019-01-010000-00-00NoNoCurrent