Cyclobenzaprine Hydrochloride

Product NDC
71335-2110
11-digit product format
713352110
Labeler code
71335
Product ID
71335-2110_b42f29d6-e72c-4942-8372-22e2531ab949
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
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2110-07133521100040 TABLET, FILM COATED in 1 BOTTLE (71335-2110-0) 2022-06-200000-00-00NoNoCurrent
71335-2110-17133521100114 TABLET, FILM COATED in 1 BOTTLE (71335-2110-1) 2022-06-200000-00-00NoNoCurrent
71335-2110-27133521100284 TABLET, FILM COATED in 1 BOTTLE (71335-2110-2) 2022-06-200000-00-00NoNoCurrent
71335-2110-37133521100330 TABLET, FILM COATED in 1 BOTTLE (71335-2110-3) 2022-06-200000-00-00NoNoCurrent
71335-2110-47133521100420 TABLET, FILM COATED in 1 BOTTLE (71335-2110-4) 2022-06-200000-00-00NoNoCurrent
71335-2110-57133521100515 TABLET, FILM COATED in 1 BOTTLE (71335-2110-5) 2022-06-200000-00-00NoNoCurrent
71335-2110-67133521100660 TABLET, FILM COATED in 1 BOTTLE (71335-2110-6) 2022-06-200000-00-00NoNoCurrent
71335-2110-77133521100790 TABLET, FILM COATED in 1 BOTTLE (71335-2110-7) 2022-06-200000-00-00NoNoCurrent
71335-2110-87133521100856 TABLET, FILM COATED in 1 BOTTLE (71335-2110-8) 2022-06-200000-00-00NoNoCurrent
71335-2110-971335211009120 TABLET, FILM COATED in 1 BOTTLE (71335-2110-9) 2022-06-200000-00-00NoNoCurrent