FDA.reportPublic FDA data

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

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
71335-2110-0Cyclobenzaprine Hydrochloride40 in 1 BOTTLETABLET, FILM COATED40104
71335-2110-1Cyclobenzaprine Hydrochloride14 in 1 BOTTLETABLET, FILM COATED14104
71335-2110-2Cyclobenzaprine Hydrochloride84 in 1 BOTTLETABLET, FILM COATED84104
71335-2110-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30104
71335-2110-4Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED20104
71335-2110-5Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED15104
71335-2110-6Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60104
71335-2110-7Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90104
71335-2110-8Cyclobenzaprine Hydrochloride56 in 1 BOTTLETABLET, FILM COATED56104
71335-2110-9Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED120104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2110-0EA - Each71335-211082254638-db1c-43ec-a5e6-f777559f947012022-12-07
71335-2110-1EA - Each71335-2110c6574789-fd3e-4925-80ba-a4b93906600012022-12-07
71335-2110-3EA - Each71335-21102d8e25ff-c90e-404f-b2e3-3b3f97ac767a12022-12-07
71335-2110-4EA - Each71335-2110e1710da1-0508-48d7-b520-8893d8d187fc12022-12-07
71335-2110-5EA - Each71335-2110667119e7-3c68-43ab-97ed-b03e371eb3ea12022-12-07
71335-2110-6EA - Each71335-2110dec8d665-b85d-4e2e-95b6-f10d2469dea512022-11-07
71335-2110-7EA - Each71335-2110769bf07e-b9f9-41ae-acc3-2752e914192112022-12-07
71335-2110-9EA - Each71335-2110ec21a07d-575d-43a5-8312-ce292a7cb71c12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2110CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240823_193744c8-ff8e-4f65-aec1-1c13f471ac82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN193744c8-ff8e-4f65-aec1-1c13f471ac82104
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD193744c8-ff8e-4f65-aec1-1c13f471ac82104

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