FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
71335-1962
11-digit product format
713351962
Labeler code
71335
Product ID
71335-1962_081b5e7c-a504-8d76-e063-6294a90a821f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213324
Marketing category
ANDA
Marketing start
2020-07-06
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
71335-1962-0Cyclobenzaprine hydrochloride40 in 1 BOTTLETABLET, FILM COATED40103
71335-1962-1Cyclobenzaprine hydrochloride14 in 1 BOTTLETABLET, FILM COATED14103
71335-1962-2Cyclobenzaprine hydrochloride84 in 1 BOTTLETABLET, FILM COATED84103
71335-1962-3Cyclobenzaprine hydrochloride30 in 1 BOTTLETABLET, FILM COATED30103
71335-1962-4Cyclobenzaprine hydrochloride20 in 1 BOTTLETABLET, FILM COATED20103
71335-1962-5Cyclobenzaprine hydrochloride15 in 1 BOTTLETABLET, FILM COATED15103
71335-1962-6Cyclobenzaprine hydrochloride60 in 1 BOTTLETABLET, FILM COATED60103
71335-1962-7Cyclobenzaprine hydrochloride90 in 1 BOTTLETABLET, FILM COATED90103
71335-1962-8Cyclobenzaprine hydrochloride56 in 1 BOTTLETABLET, FILM COATED56103
71335-1962-9Cyclobenzaprine hydrochloride120 in 1 BOTTLETABLET, FILM COATED120103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1962-1EA - Each71335-1962b1894169-b972-45f7-bffa-dc37871b63e412022-03-09
71335-1962-3EA - Each71335-19623cbc40b7-11a3-4922-89f4-98583f8cdd3712022-03-09
71335-1962-6EA - Each71335-19626ebcd129-ca07-4e06-ae12-33a8a02acadc12022-03-09
71335-1962-7EA - Each71335-19620a173c21-30d7-449d-9f26-788b841a190e12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1962CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20231020_4a2d3cae-5c64-4986-9707-cc213b70b7ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4a2d3cae-5c64-4986-9707-cc213b70b7ad103
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4a2d3cae-5c64-4986-9707-cc213b70b7ad103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1962-07133519620040 TABLET, FILM COATED in 1 BOTTLE (71335-1962-0) 2022-02-140000-00-00NoNoCurrent
71335-1962-17133519620114 TABLET, FILM COATED in 1 BOTTLE (71335-1962-1) 2021-10-110000-00-00NoNoCurrent
71335-1962-27133519620284 TABLET, FILM COATED in 1 BOTTLE (71335-1962-2) 2022-02-140000-00-00NoNoCurrent
71335-1962-37133519620330 TABLET, FILM COATED in 1 BOTTLE (71335-1962-3) 2021-10-080000-00-00NoNoCurrent
71335-1962-47133519620420 TABLET, FILM COATED in 1 BOTTLE (71335-1962-4) 2021-10-080000-00-00NoNoCurrent
71335-1962-57133519620515 TABLET, FILM COATED in 1 BOTTLE (71335-1962-5) 2021-12-300000-00-00NoNoCurrent
71335-1962-67133519620660 TABLET, FILM COATED in 1 BOTTLE (71335-1962-6) 2021-10-080000-00-00NoNoCurrent
71335-1962-77133519620790 TABLET, FILM COATED in 1 BOTTLE (71335-1962-7) 2021-10-080000-00-00NoNoCurrent
71335-1962-87133519620856 TABLET, FILM COATED in 1 BOTTLE (71335-1962-8) 2022-02-140000-00-00NoNoCurrent
71335-1962-971335196209120 TABLET, FILM COATED in 1 BOTTLE (71335-1962-9) 2021-11-160000-00-00NoNoCurrent