FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
76420-830
11-digit product format
764200830
Labeler code
76420
Product ID
76420-830_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
10 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 HYDROCHLORIDE10 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
76420-830-00CYCLOBENZAPRINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10002
76420-830-01CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1002
76420-830-05CYCLOBENZAPRINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5002
76420-830-07CYCLOBENZAPRINE HYDROCHLORIDE7 in 1 BOTTLETABLET, FILM COATED72
76420-830-12CYCLOBENZAPRINE HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1202
76420-830-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302
76420-830-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED602
76420-830-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-830-00EA - Each76420-8309d9a4a0d-354d-4bbb-964c-308ef55c5f6d12024-10-04
76420-830-01EA - Each76420-8300b21efef-5df6-41c5-bd6c-16f198df59e512024-10-04
76420-830-05EA - Each76420-83067903018-6f5f-446f-8129-89abecd6627712024-10-04
76420-830-12EA - Each76420-83041d616ae-1335-43c3-8dfc-1d40ab6b7c0d12024-10-04
76420-830-30EA - Each76420-830aa3da903-be88-4b69-87e2-70041b397d3712024-10-04
76420-830-60EA - Each76420-830d80526ed-92e2-468f-b62b-e7d6f19cac3812024-10-04
76420-830-90EA - Each76420-8307fb3a4fb-33ba-4c43-9764-80060bd882d612024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-830CYCLOBENZAPRINE 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
76420-830-00764200830001000 TABLET, FILM COATED in 1 BOTTLE (76420-830-00) 2024-07-02NoNoHistorical
76420-830-0176420083001100 TABLET, FILM COATED in 1 BOTTLE (76420-830-01) 2024-07-02NoNoHistorical
76420-830-0576420083005500 TABLET, FILM COATED in 1 BOTTLE (76420-830-05) 2024-07-02NoNoHistorical
76420-830-07764200830077 TABLET, FILM COATED in 1 BOTTLE (76420-830-07) 2024-07-02NoNoHistorical
76420-830-1276420083012120 TABLET, FILM COATED in 1 BOTTLE (76420-830-12) 2024-07-02NoNoHistorical
76420-830-307642008303030 TABLET, FILM COATED in 1 BOTTLE (76420-830-30) 2024-07-02NoNoHistorical
76420-830-607642008306060 TABLET, FILM COATED in 1 BOTTLE (76420-830-60) 2024-07-02NoNoHistorical
76420-830-907642008309090 TABLET, FILM COATED in 1 BOTTLE (76420-830-90) 2024-07-02NoNoHistorical