FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
76420-269
11-digit product format
764200269
Labeler code
76420
Product ID
76420-269_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
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
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
76420-269-01Cyclobenzaprine Hydrochloride1 in 1 BOTTLETABLET, FILM COATED11
76420-269-02Cyclobenzaprine Hydrochloride2 in 1 BOTTLETABLET, FILM COATED21
76420-269-07Cyclobenzaprine Hydrochloride7 in 1 BOTTLETABLET, FILM COATED71
76420-269-10Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
76420-269-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED151
76420-269-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED201
76420-269-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
76420-269-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
76420-269-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-269-01EA - Each76420-269011eb04b-1dae-4a21-9365-527dd3d6a96812022-10-06
76420-269-02EA - Each76420-269b3454f4e-a8fd-4df4-a0fc-e7f201fe6de912022-10-06
76420-269-07EA - Each76420-269dd533d0f-e6d9-4cf1-b199-77a11c47cadf12022-10-06
76420-269-10EA - Each76420-26990605055-7bf6-4b53-90a4-bde6a82bb8fa12022-10-06
76420-269-15EA - Each76420-26909c72814-9c3c-447a-b6f4-e89c0bea227412022-10-06
76420-269-20EA - Each76420-26969233249-25e2-4eb0-b5a3-5de621271c8d12022-10-06
76420-269-30EA - Each76420-26961fedbc4-a8e4-40cf-8d0c-26d3cd41570312022-10-06
76420-269-60EA - Each76420-2699d512709-7f8e-49a4-8773-0546d854ec6212022-10-06
76420-269-90EA - Each76420-2691fc136d9-e7a9-4963-bfc3-ea2b1282725812022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-269CYCLOBENZAPRINE 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
76420-269-01764200269011 TABLET, FILM COATED in 1 BOTTLE (76420-269-01) 2022-09-030000-00-00NoNoCurrent
76420-269-02764200269022 TABLET, FILM COATED in 1 BOTTLE (76420-269-02) 2022-09-030000-00-00NoNoCurrent
76420-269-07764200269077 TABLET, FILM COATED in 1 BOTTLE (76420-269-07) 2022-09-030000-00-00NoNoCurrent
76420-269-1076420026910100 TABLET, FILM COATED in 1 BOTTLE (76420-269-10) 2022-09-030000-00-00NoNoCurrent
76420-269-157642002691515 TABLET, FILM COATED in 1 BOTTLE (76420-269-15) 2022-09-030000-00-00NoNoCurrent
76420-269-207642002692020 TABLET, FILM COATED in 1 BOTTLE (76420-269-20) 2022-09-030000-00-00NoNoCurrent
76420-269-307642002693030 TABLET, FILM COATED in 1 BOTTLE (76420-269-30) 2022-09-030000-00-00NoNoCurrent
76420-269-607642002696060 TABLET, FILM COATED in 1 BOTTLE (76420-269-60) 2022-09-030000-00-00NoNoCurrent
76420-269-907642002699090 TABLET, FILM COATED in 1 BOTTLE (76420-269-90) 2022-09-030000-00-00NoNoCurrent