FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
71335-1099
11-digit product format
713351099
Labeler code
71335
Product ID
71335-1099_e1d36423-2d90-4161-933c-86e83e8c14a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
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, 828348

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
71335-1099-0CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1004
71335-1099-1CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED304
71335-1099-2CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED904
71335-1099-3CYCLOBENZAPRINE HYDROCHLORIDE21 in 1 BOTTLETABLET, FILM COATED214
71335-1099-4CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED104
71335-1099-5CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED154
71335-1099-6CYCLOBENZAPRINE HYDROCHLORIDE40 in 1 BOTTLETABLET, FILM COATED404
71335-1099-7CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED604
71335-1099-8CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED204
71335-1099-9CYCLOBENZAPRINE HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1099-1EA - Each71335-10998e404eb3-aae2-44ab-acfb-6c02fc06d3e612019-10-07
71335-1099-2EA - Each71335-109997518737-6102-4e76-93a6-26f5c22e420012019-10-07
71335-1099-3EA - Each71335-1099cbba3bd0-5984-41ce-ae64-b07d1fc2094012019-10-07
71335-1099-5EA - Each71335-1099dcaabb8f-9830-4e58-b31d-5ab361befdce12019-10-07
71335-1099-7EA - Each71335-10990160b2a6-8e07-49a9-9f53-1441e474d9df12019-09-05
71335-1099-8EA - Each71335-109915b7e4e6-e7bc-4c1a-84d2-52c6c96deda912019-10-07
71335-1099-9EA - Each71335-109964835135-c6ed-461e-9c8f-7c3f8d3b046b12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1099CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20231019_85128989-bfa3-4b82-94c1-f90b14ccd2f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN85128989-bfa3-4b82-94c1-f90b14ccd2f94
828320cyclobenzaprine HCl 5 MG Oral TabletPSN85128989-bfa3-4b82-94c1-f90b14ccd2f94
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD85128989-bfa3-4b82-94c1-f90b14ccd2f94
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD85128989-bfa3-4b82-94c1-f90b14ccd2f94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1099-071335109900100 TABLET, FILM COATED in 1 BOTTLE (71335-1099-0) 2019-02-220000-00-00NoNoCurrent
71335-1099-17133510990130 TABLET, FILM COATED in 1 BOTTLE (71335-1099-1) 2019-02-220000-00-00NoNoCurrent
71335-1099-27133510990290 TABLET, FILM COATED in 1 BOTTLE (71335-1099-2) 2019-02-220000-00-00NoNoCurrent
71335-1099-37133510990321 TABLET, FILM COATED in 1 BOTTLE (71335-1099-3) 2019-02-220000-00-00NoNoCurrent
71335-1099-47133510990410 TABLET, FILM COATED in 1 BOTTLE (71335-1099-4) 2019-02-220000-00-00NoNoCurrent
71335-1099-57133510990515 TABLET, FILM COATED in 1 BOTTLE (71335-1099-5) 2019-02-220000-00-00NoNoCurrent
71335-1099-67133510990640 TABLET, FILM COATED in 1 BOTTLE (71335-1099-6) 2019-02-220000-00-00NoNoCurrent
71335-1099-77133510990760 TABLET, FILM COATED in 1 BOTTLE (71335-1099-7) 2019-02-220000-00-00NoNoCurrent
71335-1099-87133510990820 TABLET, FILM COATED in 1 BOTTLE (71335-1099-8) 2019-02-220000-00-00NoNoCurrent
71335-1099-971335109909120 TABLET, FILM COATED in 1 BOTTLE (71335-1099-9) 2019-02-220000-00-00NoNoCurrent