FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
71335-1961
11-digit product format
713351961
Labeler code
71335
Product ID
71335-1961_9bb215d0-276c-4c70-a4f9-f9e20b9f3cdf
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
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

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
71335-1961-0Cyclobenzaprine hydrochloride100 in 1 BOTTLETABLET, FILM COATED100102
71335-1961-1Cyclobenzaprine hydrochloride30 in 1 BOTTLETABLET, FILM COATED30102
71335-1961-2Cyclobenzaprine hydrochloride90 in 1 BOTTLETABLET, FILM COATED90102
71335-1961-3Cyclobenzaprine hydrochloride21 in 1 BOTTLETABLET, FILM COATED21102
71335-1961-4Cyclobenzaprine hydrochloride10 in 1 BOTTLETABLET, FILM COATED10102
71335-1961-5Cyclobenzaprine hydrochloride15 in 1 BOTTLETABLET, FILM COATED15102
71335-1961-6Cyclobenzaprine hydrochloride40 in 1 BOTTLETABLET, FILM COATED40102
71335-1961-7Cyclobenzaprine hydrochloride60 in 1 BOTTLETABLET, FILM COATED60102
71335-1961-8Cyclobenzaprine hydrochloride20 in 1 BOTTLETABLET, FILM COATED20102
71335-1961-9Cyclobenzaprine hydrochloride120 in 1 BOTTLETABLET, FILM COATED120102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1961-1EA - Each71335-1961fdc72b7e-9102-4cd2-aa51-d5cb62d9924012022-05-04
71335-1961-2EA - Each71335-19619eb9abd1-47a0-4db0-87ed-d9f6bff218aa12022-07-06
71335-1961-3EA - Each71335-19611fde98fe-45ca-46fb-a16d-191ad373b74512022-07-06
71335-1961-4EA - Each71335-19619613a741-fa87-443a-b7b8-64df8a58403412022-07-06
71335-1961-5EA - Each71335-19614ee95191-7402-47ce-b2ed-338afdd0cc0712022-07-06
71335-1961-7EA - Each71335-19617cffceac-bb15-4e26-b0c5-97a9eb7fbee012022-03-09
71335-1961-9EA - Each71335-196120c45b47-5c50-4e34-9ed2-5f1b0cb6979312022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1961CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20230328_6ebaccfc-f57c-4547-ade0-6a6e204f5ea0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN6ebaccfc-f57c-4547-ade0-6a6e204f5ea0102
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD6ebaccfc-f57c-4547-ade0-6a6e204f5ea0102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1961-071335196100100 TABLET, FILM COATED in 1 BOTTLE (71335-1961-0) 2022-02-140000-00-00NoNoCurrent
71335-1961-17133519610130 TABLET, FILM COATED in 1 BOTTLE (71335-1961-1) 2021-10-290000-00-00NoNoCurrent
71335-1961-27133519610290 TABLET, FILM COATED in 1 BOTTLE (71335-1961-2) 2021-10-280000-00-00NoNoCurrent
71335-1961-37133519610321 TABLET, FILM COATED in 1 BOTTLE (71335-1961-3) 2022-02-140000-00-00NoNoCurrent
71335-1961-47133519610410 TABLET, FILM COATED in 1 BOTTLE (71335-1961-4) 2022-02-140000-00-00NoNoCurrent
71335-1961-57133519610515 TABLET, FILM COATED in 1 BOTTLE (71335-1961-5) 2021-10-120000-00-00NoNoCurrent
71335-1961-67133519610640 TABLET, FILM COATED in 1 BOTTLE (71335-1961-6) 2022-02-140000-00-00NoNoCurrent
71335-1961-77133519610760 TABLET, FILM COATED in 1 BOTTLE (71335-1961-7) 2021-10-290000-00-00NoNoCurrent
71335-1961-87133519610820 TABLET, FILM COATED in 1 BOTTLE (71335-1961-8) 2022-02-140000-00-00NoNoCurrent
71335-1961-971335196109120 TABLET, FILM COATED in 1 BOTTLE (71335-1961-9) 2021-10-200000-00-00NoNoCurrent