FDA.reportPublic FDA data

CYCLOBENZAPRINE

Product NDC
61919-305
11-digit product format
619190305
Labeler code
61919
Product ID
61919-305_85b970be-5790-0779-e053-2a91aa0ae1e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090478
Marketing category
ANDA
Marketing start
2016-12-16
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-305-302025-01-30C16284748780-12cef2736-aeea-d83d-e063-dadaa90ab31fCYCLOBENZAPRINE HYDROCHLORIDE
61919-305-602025-01-30C16284748780-12cef2736-aeea-d83d-e063-dadaa90ab31fCYCLOBENZAPRINE HYDROCHLORIDE
61919-305-902025-01-30C16284748780-12cef2736-aeea-d83d-e063-dadaa90ab31fCYCLOBENZAPRINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-305-30CYCLOBENZAPRINE30 in 1 BOTTLETABLET, FILM COATED303
61919-305-60CYCLOBENZAPRINE60 in 1 BOTTLETABLET, FILM COATED603
61919-305-90CYCLOBENZAPRINE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-305-30EA - Each61919-305bb9097b5-54ff-4b13-8c1c-9b2d6c361b9512017-03-06
61919-305-60EA - Each61919-305d7f01f15-bb76-4b82-8e85-900d7645da6a12017-03-06
61919-305-90EA - Each61919-3059a24c517-1f2a-4c16-8333-49490ce1eec612017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-305CYCLOBENZAPRINE TABLET, FILM COATED CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 3 package rows20230418_43cc254b-6633-63dd-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN43cc254b-6633-63dd-e054-00144ff88e883
828320cyclobenzaprine HCl 5 MG Oral TabletPSN43cc254b-6633-63dd-e054-00144ff88e883
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD43cc254b-6633-63dd-e054-00144ff88e883
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD43cc254b-6633-63dd-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-305-306191903053030 TABLET, FILM COATED in 1 BOTTLE (61919-305-30) 2016-12-160000-00-00NoNoCurrent
61919-305-606191903056060 TABLET, FILM COATED in 1 BOTTLE (61919-305-60) 2016-12-160000-00-00NoNoCurrent
61919-305-906191903059090 TABLET, FILM COATED in 1 BOTTLE (61919-305-90) 2016-12-160000-00-00NoNoCurrent