Cyclobenzaprine Hydrochloride

Product NDC
71335-2666
11-digit product format
713352666
Labeler code
71335
Product ID
71335-2666_71c2dd8a-818a-444b-bdfb-9f8b6bc55f3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA218936
Marketing category
ANDA
Marketing start
2025-02-19
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2666-07133526660040 TABLET in 1 BOTTLE (71335-2666-0) 40 tablet2025-07-14NoNoHistorical
71335-2666-17133526660114 TABLET in 1 BOTTLE (71335-2666-1) 14 tablet2025-07-14NoNoHistorical
71335-2666-27133526660284 TABLET in 1 BOTTLE (71335-2666-2) 84 tablet2025-07-14NoNoHistorical
71335-2666-37133526660330 TABLET in 1 BOTTLE (71335-2666-3) 30 tablet2025-07-14NoNoHistorical
71335-2666-47133526660420 TABLET in 1 BOTTLE (71335-2666-4) 20 tablet2025-07-14NoNoHistorical
71335-2666-57133526660515 TABLET in 1 BOTTLE (71335-2666-5) 15 tablet2025-07-14NoNoHistorical
71335-2666-67133526660660 TABLET in 1 BOTTLE (71335-2666-6) 60 tablet2025-07-14NoNoHistorical
71335-2666-77133526660790 TABLET in 1 BOTTLE (71335-2666-7) 90 tablet2025-07-14NoNoHistorical
71335-2666-87133526660856 TABLET in 1 BOTTLE (71335-2666-8) 56 tablet2025-07-14NoNoHistorical
71335-2666-971335266609120 TABLET in 1 BOTTLE (71335-2666-9) 120 tablet2025-07-14NoNoHistorical