FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
16571-783
11-digit product format
165710783
Labeler code
16571
Product ID
16571-783_0280b504-4a42-44f3-8a1a-34a20eac054a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA078643
Marketing category
ANDA
Marketing start
2008-09-26
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
Rxcui828320, 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
16571-783-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
16571-783-10Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10001
16571-783-50Cyclobenzaprine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-783-01EA - Each16571-783e72eb478-fd20-4000-ad92-3c2cf588886512021-11-09
16571-783-10EA - Each16571-783d28fd731-67cd-45d8-ae93-e518022b95ec12021-11-09
16571-783-50EA - Each16571-78367e2485d-c727-41da-b42a-587504f3ec8712021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-783CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]1Current NDC, Legacy NDC, 3 package rows20210626_0280b504-4a42-44f3-8a1a-34a20eac054a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN193744c8-ff8e-4f65-aec1-1c13f471ac82104
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD193744c8-ff8e-4f65-aec1-1c13f471ac82104
828348cyclobenzaprine HCl 10 MG Oral TabletPSNb09ca979-ab6b-441b-a66f-41ca32eae6cb13
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDb09ca979-ab6b-441b-a66f-41ca32eae6cb13
828348cyclobenzaprine HCl 10 MG Oral TabletPSNe4ed7ad2-cf58-4fdb-bc8c-d89f23b012107
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDe4ed7ad2-cf58-4fdb-bc8c-d89f23b012107
828348cyclobenzaprine HCl 10 MG Oral TabletPSN014dd648-5b84-4d1d-80fc-a467e2d741ef5
828348cyclobenzaprine HCl 10 MG Oral TabletPSNdb49801d-9bde-5dd0-e053-2a95a90aee535
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDdb49801d-9bde-5dd0-e053-2a95a90aee535
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD014dd648-5b84-4d1d-80fc-a467e2d741ef5
828348cyclobenzaprine HCl 10 MG Oral TabletPSN09d35c34-11fa-3a5d-e063-6294a90ab1724
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD09d35c34-11fa-3a5d-e063-6294a90ab1724
828348cyclobenzaprine HCl 10 MG Oral TabletPSN508e310e-067a-4f95-869a-e1da49aabe943
828320cyclobenzaprine HCl 5 MG Oral TabletPSN508e310e-067a-4f95-869a-e1da49aabe943
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD508e310e-067a-4f95-869a-e1da49aabe943
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD508e310e-067a-4f95-869a-e1da49aabe943
828348cyclobenzaprine HCl 10 MG Oral TabletPSNdd7d56f0-bed5-21c3-e053-2a95a90a746f2
828348cyclobenzaprine HCl 10 MG Oral TabletPSNfc61c9f5-b0ec-3ff8-e053-6394a90adeb72
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDdd7d56f0-bed5-21c3-e053-2a95a90a746f2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDfc61c9f5-b0ec-3ff8-e053-6394a90adeb72
828348cyclobenzaprine HCl 10 MG Oral TabletPSN74af1727-e84f-4dad-82be-045e7d23beaf1
828348cyclobenzaprine HCl 10 MG Oral TabletPSN12645f19-fffc-8b08-e063-6394a90a5c551
828348cyclobenzaprine HCl 10 MG Oral TabletPSNcc93038f-1202-47f3-a959-2877877cc8691
828348cyclobenzaprine HCl 10 MG Oral TabletPSN0280b504-4a42-44f3-8a1a-34a20eac054a1
828320cyclobenzaprine HCl 5 MG Oral TabletPSN0280b504-4a42-44f3-8a1a-34a20eac054a1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD74af1727-e84f-4dad-82be-045e7d23beaf1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD12645f19-fffc-8b08-e063-6394a90a5c551
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDcc93038f-1202-47f3-a959-2877877cc8691
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD0280b504-4a42-44f3-8a1a-34a20eac054a1
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD0280b504-4a42-44f3-8a1a-34a20eac054a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-783-0116571078301100 TABLET, FILM COATED in 1 BOTTLE (16571-783-01) 2008-09-260000-00-00NoNoCurrent
16571-783-10165710783101000 TABLET, FILM COATED in 1 BOTTLE (16571-783-10) 2008-09-260000-00-00NoNoCurrent
16571-783-5016571078350500 TABLET, FILM COATED in 1 BOTTLE (16571-783-50) 2008-09-260000-00-00NoNoCurrent