CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
71335-2479
11-digit product format
713352479
Labeler code
71335
Product ID
71335-2479_3444cb0d-8533-4f81-82fd-ab7cda8fec21
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

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
71335-2479-0CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1002
71335-2479-1CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302
71335-2479-2CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED902
71335-2479-3CYCLOBENZAPRINE HYDROCHLORIDE21 in 1 BOTTLETABLET, FILM COATED212
71335-2479-4CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED102
71335-2479-5CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED152
71335-2479-6CYCLOBENZAPRINE HYDROCHLORIDE40 in 1 BOTTLETABLET, FILM COATED402
71335-2479-7CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED602
71335-2479-8CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED202
71335-2479-9CYCLOBENZAPRINE HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2479-1EA - Each71335-24792f393a39-0221-41eb-b5ae-0876c927206e12025-08-11
71335-2479-2EA - Each71335-247947a57c6d-36fb-485f-8026-485213cbd8f812025-12-16
71335-2479-7EA - Each71335-2479ac4ee525-7bc8-4376-83bd-f5c7aad4e31312025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2479CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2Current NDC, 10 package rows20250303_05641925-7b10-4b30-b6e8-44b416a5e77e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN05641925-7b10-4b30-b6e8-44b416a5e77e2
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD05641925-7b10-4b30-b6e8-44b416a5e77e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2479-071335247900100 TABLET, FILM COATED in 1 BOTTLE (71335-2479-0) 2025-02-03NoNoHistorical
71335-2479-17133524790130 TABLET, FILM COATED in 1 BOTTLE (71335-2479-1) 2024-09-24NoNoHistorical
71335-2479-27133524790290 TABLET, FILM COATED in 1 BOTTLE (71335-2479-2) 2024-11-08NoNoHistorical
71335-2479-37133524790321 TABLET, FILM COATED in 1 BOTTLE (71335-2479-3) 2024-10-08NoNoHistorical
71335-2479-47133524790410 TABLET, FILM COATED in 1 BOTTLE (71335-2479-4) 2025-02-03NoNoHistorical
71335-2479-57133524790515 TABLET, FILM COATED in 1 BOTTLE (71335-2479-5) 2024-09-13NoNoHistorical
71335-2479-67133524790640 TABLET, FILM COATED in 1 BOTTLE (71335-2479-6) 2024-11-13NoNoHistorical
71335-2479-77133524790760 TABLET, FILM COATED in 1 BOTTLE (71335-2479-7) 2024-09-12NoNoHistorical
71335-2479-87133524790820 TABLET, FILM COATED in 1 BOTTLE (71335-2479-8) 2025-01-14NoNoHistorical
71335-2479-971335247909120 TABLET, FILM COATED in 1 BOTTLE (71335-2479-9) 2024-09-12NoNoHistorical