FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
76420-828
11-digit product format
764200828
Labeler code
76420
Product ID
76420-828_2d48e425-7718-63fa-e063-6394a90ab107
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
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
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
76420-828-00CYCLOBENZAPRINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10002
76420-828-01CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1002
76420-828-05CYCLOBENZAPRINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5002
76420-828-07CYCLOBENZAPRINE HYDROCHLORIDE7 in 1 BOTTLETABLET, FILM COATED72
76420-828-12CYCLOBENZAPRINE HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1202
76420-828-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302
76420-828-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED602
76420-828-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-828-00EA - Each76420-8282e4ea8e2-a3c7-4fb3-b12d-6a1b975ea04912024-10-04
76420-828-01EA - Each76420-82880e4b6f3-329b-411b-b854-cf0aa72e81a812024-10-04
76420-828-05EA - Each76420-828acc61efb-03cd-43a9-b47e-bcc4e02aeb0b12024-10-04
76420-828-12EA - Each76420-8287319dde6-5cdc-4b1c-ba05-41879063676012024-10-04
76420-828-30EA - Each76420-82848f3824e-01c9-4be8-8e29-25237f0cb27012024-10-04
76420-828-60EA - Each76420-828f39058f5-ad87-4c7d-938e-9dc22be5df7312024-10-04
76420-828-90EA - Each76420-828bab73cbc-e3d4-42b7-beec-01d14ce4f7b212024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-828CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.]2Current NDC, 8 package rows20250205_418e3974-f7dd-4f27-bee5-3c2fb0531c4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828320cyclobenzaprine HCl 5 MG Oral TabletPSN418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD418e3974-f7dd-4f27-bee5-3c2fb0531c4c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-828-00764200828001000 TABLET, FILM COATED in 1 BOTTLE (76420-828-00) 2024-07-02NoNoHistorical
76420-828-0176420082801100 TABLET, FILM COATED in 1 BOTTLE (76420-828-01) 2024-07-02NoNoHistorical
76420-828-0576420082805500 TABLET, FILM COATED in 1 BOTTLE (76420-828-05) 2024-07-02NoNoHistorical
76420-828-07764200828077 TABLET, FILM COATED in 1 BOTTLE (76420-828-07) 2025-02-04NoNoHistorical
76420-828-1276420082812120 TABLET, FILM COATED in 1 BOTTLE (76420-828-12) 2024-07-02NoNoHistorical
76420-828-307642008283030 TABLET, FILM COATED in 1 BOTTLE (76420-828-30) 2024-07-02NoNoHistorical
76420-828-607642008286060 TABLET, FILM COATED in 1 BOTTLE (76420-828-60) 2024-07-02NoNoHistorical
76420-828-907642008289090 TABLET, FILM COATED in 1 BOTTLE (76420-828-90) 2024-07-02NoNoHistorical