FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
76420-829
11-digit product format
764200829
Labeler code
76420
Product ID
76420-829_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
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
76420-829-01CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1002
76420-829-07CYCLOBENZAPRINE HYDROCHLORIDE7 in 1 BOTTLETABLET, FILM COATED72
76420-829-12CYCLOBENZAPRINE HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1202
76420-829-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302
76420-829-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED602
76420-829-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-829-01EA - Each76420-8293b2c6bfb-2ecc-4399-a0cb-b363f232075412024-10-04
76420-829-12EA - Each76420-829f27335c2-34b1-4a55-b4d2-df9f45b166a312024-10-04
76420-829-30EA - Each76420-829e72ec174-b240-475a-b9bd-0f281d1c120612024-10-04
76420-829-60EA - Each76420-829ad9c6c3f-d14e-46c6-a55c-8a45f9277e0e12024-10-04
76420-829-90EA - Each76420-829d5d0f49d-e7bd-4afd-9f6f-89dd67fdd5ae12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-829CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.]2Current NDC, 6 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
76420-829-0176420082901100 TABLET, FILM COATED in 1 BOTTLE (76420-829-01) 2024-07-02NoNoHistorical
76420-829-07764200829077 TABLET, FILM COATED in 1 BOTTLE (76420-829-07) 2025-02-04NoNoHistorical
76420-829-1276420082912120 TABLET, FILM COATED in 1 BOTTLE (76420-829-12) 2024-07-02NoNoHistorical
76420-829-307642008293030 TABLET, FILM COATED in 1 BOTTLE (76420-829-30) 2024-07-02NoNoHistorical
76420-829-607642008296060 TABLET, FILM COATED in 1 BOTTLE (76420-829-60) 2024-07-02NoNoHistorical
76420-829-907642008299090 TABLET, FILM COATED in 1 BOTTLE (76420-829-90) 2024-07-02NoNoHistorical