FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
52817-330
11-digit product format
528170330
Labeler code
52817
Product ID
52817-330_b8c3dbd2-89f7-215b-e053-2995a90a7f74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TruPharma LLC
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
52817-330-10CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1004
52817-330-50CYCLOBENZAPRINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-330-10EA - Each52817-3309d734e61-a0d1-4e9e-9a80-313a9fd172e812018-06-11
52817-330-50EA - Each52817-3302508744d-4dae-45b5-95b1-bbd0565c097312018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-330CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [TRUPHARMA LLC]4Current NDC, Legacy NDC, 2 package rows20210114_08adc97f-feef-46fb-ac75-f015b4f3a43a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNf2eb32c3-3da0-4938-9ed9-ea8420450fde13
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDf2eb32c3-3da0-4938-9ed9-ea8420450fde13
828320cyclobenzaprine HCl 5 MG Oral TabletPSNceb56ab8-4a76-6dee-e053-2995a90aab309
828320cyclobenzaprine HCl 5 MG Oral TabletPSNafca1267-4d8f-7453-e053-2995a90a865c9
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDceb56ab8-4a76-6dee-e053-2995a90aab309
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDafca1267-4d8f-7453-e053-2995a90a865c9
828320cyclobenzaprine HCl 5 MG Oral TabletPSN7c732db1-8321-82a4-e053-2991aa0aa8a06
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD7c732db1-8321-82a4-e053-2991aa0aa8a06
828320cyclobenzaprine HCl 5 MG Oral TabletPSN34ff8a08-0177-451f-9dbc-e215823461965
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD34ff8a08-0177-451f-9dbc-e215823461965
828348cyclobenzaprine HCl 10 MG Oral TabletPSN85128989-bfa3-4b82-94c1-f90b14ccd2f94
828348cyclobenzaprine HCl 10 MG Oral TabletPSN08adc97f-feef-46fb-ac75-f015b4f3a43a4
828320cyclobenzaprine HCl 5 MG Oral TabletPSN85128989-bfa3-4b82-94c1-f90b14ccd2f94
828320cyclobenzaprine HCl 5 MG Oral TabletPSN08adc97f-feef-46fb-ac75-f015b4f3a43a4
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN08adc97f-feef-46fb-ac75-f015b4f3a43a4
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD85128989-bfa3-4b82-94c1-f90b14ccd2f94
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD08adc97f-feef-46fb-ac75-f015b4f3a43a4
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD85128989-bfa3-4b82-94c1-f90b14ccd2f94
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD08adc97f-feef-46fb-ac75-f015b4f3a43a4
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD08adc97f-feef-46fb-ac75-f015b4f3a43a4
828320cyclobenzaprine HCl 5 MG Oral TabletPSNc29cf8bd-2f63-ed4b-e053-2995a90ab6eb3
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDc29cf8bd-2f63-ed4b-e053-2995a90ab6eb3
828320cyclobenzaprine HCl 5 MG Oral TabletPSN751f0d33-ceff-40b0-9329-9125f176e06a2
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD751f0d33-ceff-40b0-9329-9125f176e06a2
828320cyclobenzaprine HCl 5 MG Oral TabletPSN5023b8a5-c9df-84a4-e063-6294a90a96061
828320cyclobenzaprine HCl 5 MG Oral TabletPSN4dcbdf8f-37ce-0f90-e063-6394a90ae83c1
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD5023b8a5-c9df-84a4-e063-6294a90a96061
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD4dcbdf8f-37ce-0f90-e063-6394a90ae83c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52817-330-1052817033010100 TABLET, FILM COATED in 1 BOTTLE (52817-330-10) 2017-05-310000-00-00NoNoCurrent
52817-330-5052817033050500 TABLET, FILM COATED in 1 BOTTLE (52817-330-50) 2017-05-310000-00-00NoNoCurrent