Cyclobenzaprine Hydrochloride

Product NDC
69306-872
11-digit product format
693060872
Labeler code
69306
Product ID
69306-872_426ec634-b00d-e57d-e063-6394a90a4103
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Doc Rx
Application
ANDA077563
Marketing category
ANDA
Marketing start
2025-07-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69306-872-03Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
69306-872-06Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4c054230-1978-44d2-9467-ed19946191131
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4c054230-1978-44d2-9467-ed19946191131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69306-872-036930608720330 TABLET, FILM COATED in 1 BOTTLE (69306-872-03) 2025-10-31NoNoHistorical
69306-872-066930608720660 TABLET, FILM COATED in 1 BOTTLE (69306-872-06) 2025-10-31NoNoHistorical