FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
76420-030
11-digit product format
764200030
Labeler code
76420
Product ID
76420-030_e4ec0115-3fdf-8c05-e053-2995a90a8353
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
Rxcui828320

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
76420-030-01CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1002
76420-030-05CYCLOBENZAPRINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5002
76420-030-12CYCLOBENZAPRINE HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1202
76420-030-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302
76420-030-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED602
76420-030-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-030-01EA - Each76420-030700c7fa8-c2e6-42eb-a540-64ca3d1a0e7512022-08-04
76420-030-05EA - Each76420-030432bfa05-cf0d-4c9e-953c-314def2ba39f12022-08-04
76420-030-12EA - Each76420-03083a3c975-ce75-49b2-9948-7fb3e28e8c2012022-09-12
76420-030-30EA - Each76420-03017081dea-87ee-4335-b3c8-3af5aa0a7b2f12022-08-04
76420-030-60EA - Each76420-0302664a556-9b74-4e00-973e-f614fe9b925912022-08-04
76420-030-90EA - Each76420-0301741a4cd-74ee-4814-93a3-7e8e3449785612022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-030CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 6 package rows20220730_751f0d33-ceff-40b0-9329-9125f176e06a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN751f0d33-ceff-40b0-9329-9125f176e06a2
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD751f0d33-ceff-40b0-9329-9125f176e06a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-030-0176420003001100 TABLET, FILM COATED in 1 BOTTLE (76420-030-01) 2020-06-190000-00-00NoNoCurrent
76420-030-0576420003005500 TABLET, FILM COATED in 1 BOTTLE (76420-030-05) 2020-06-190000-00-00NoNoCurrent
76420-030-1276420003012120 TABLET, FILM COATED in 1 BOTTLE (76420-030-12) 2022-07-290000-00-00NoNoCurrent
76420-030-307642000303030 TABLET, FILM COATED in 1 BOTTLE (76420-030-30) 2020-06-190000-00-00NoNoCurrent
76420-030-607642000306060 TABLET, FILM COATED in 1 BOTTLE (76420-030-60) 2020-06-190000-00-00NoNoCurrent
76420-030-907642000309090 TABLET, FILM COATED in 1 BOTTLE (76420-030-90) 2020-06-190000-00-00NoNoCurrent