FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
71205-678
11-digit product format
712050678
Labeler code
71205
Product ID
71205-678_e3998083-e3db-4052-9b5b-19d7aaa4e658
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
71205-678-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
71205-678-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
71205-678-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-678-60EA - Each71205-67867bef801-de50-4af5-a74f-61e68856fa7d12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-678CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20220731_e3998083-e3db-4052-9b5b-19d7aaa4e658.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNe3998083-e3db-4052-9b5b-19d7aaa4e6581
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDe3998083-e3db-4052-9b5b-19d7aaa4e6581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-678-307120506783030 TABLET, FILM COATED in 1 BOTTLE (71205-678-30) 2022-07-270000-00-00NoNoCurrent
71205-678-607120506786060 TABLET, FILM COATED in 1 BOTTLE (71205-678-60) 2022-07-270000-00-00NoNoCurrent
71205-678-907120506789090 TABLET, FILM COATED in 1 BOTTLE (71205-678-90) 2022-07-270000-00-00NoNoCurrent