FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
76420-268
11-digit product format
764200268
Labeler code
76420
Product ID
76420-268_e7bfa09d-7e18-d2bf-e053-2995a90a9145
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA071611
Marketing category
ANDA
Marketing start
2021-07-20
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299, 828320, 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
76420-268-01Cyclobenzaprine Hydrochloride1 in 1 BOTTLETABLET, FILM COATED11
76420-268-02Cyclobenzaprine Hydrochloride2 in 1 BOTTLETABLET, FILM COATED21
76420-268-07Cyclobenzaprine Hydrochloride7 in 1 BOTTLETABLET, FILM COATED71
76420-268-10Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
76420-268-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED151
76420-268-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED201
76420-268-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
76420-268-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
76420-268-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-268-01EA - Each76420-268c91dc650-5f4e-40b1-8dca-94d42c5d916a12022-10-06
76420-268-02EA - Each76420-2684d55d1ff-641a-4116-866c-5c41fa0eb20312022-10-06
76420-268-07EA - Each76420-2687e2520eb-962b-480a-9503-4e2166ad41d212022-10-06
76420-268-10EA - Each76420-268aaf78c2e-8681-4760-9378-7a3172d0b5d412022-10-06
76420-268-15EA - Each76420-268dac1eac6-2b9c-40e4-8db8-93c2ed35731012022-10-06
76420-268-20EA - Each76420-268f135eca7-4c76-4b67-8d19-2ba51d5a5edf12022-10-06
76420-268-30EA - Each76420-2689f76ca76-6cd8-4459-a105-77eedcc21ef212022-10-06
76420-268-60EA - Each76420-268be4926bc-cbb7-4054-abc5-66e21fc9afb712022-10-06
76420-268-90EA - Each76420-2682c852386-bafe-46c4-af91-a712ae754ee912022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-268CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 9 package rows20220908_f8dec4e2-3151-4a79-b194-a11a57ada0b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf8dec4e2-3151-4a79-b194-a11a57ada0b61
828320cyclobenzaprine HCl 5 MG Oral TabletPSNf8dec4e2-3151-4a79-b194-a11a57ada0b61
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNf8dec4e2-3151-4a79-b194-a11a57ada0b61
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDf8dec4e2-3151-4a79-b194-a11a57ada0b61
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDf8dec4e2-3151-4a79-b194-a11a57ada0b61
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDf8dec4e2-3151-4a79-b194-a11a57ada0b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-268-01764200268011 TABLET, FILM COATED in 1 BOTTLE (76420-268-01) 2022-09-030000-00-00NoNoCurrent
76420-268-02764200268022 TABLET, FILM COATED in 1 BOTTLE (76420-268-02) 2022-09-030000-00-00NoNoCurrent
76420-268-07764200268077 TABLET, FILM COATED in 1 BOTTLE (76420-268-07) 2022-09-030000-00-00NoNoCurrent
76420-268-1076420026810100 TABLET, FILM COATED in 1 BOTTLE (76420-268-10) 2022-09-030000-00-00NoNoCurrent
76420-268-157642002681515 TABLET, FILM COATED in 1 BOTTLE (76420-268-15) 2022-09-030000-00-00NoNoCurrent
76420-268-207642002682020 TABLET, FILM COATED in 1 BOTTLE (76420-268-20) 2022-09-030000-00-00NoNoCurrent
76420-268-307642002683030 TABLET, FILM COATED in 1 BOTTLE (76420-268-30) 2022-09-030000-00-00NoNoCurrent
76420-268-607642002686060 TABLET, FILM COATED in 1 BOTTLE (76420-268-60) 2022-09-030000-00-00NoNoCurrent
76420-268-907642002689090 TABLET, FILM COATED in 1 BOTTLE (76420-268-90) 2022-09-030000-00-00NoNoCurrent