FDA.reportPublic FDA data

CYCLOBENZAPRINE HCL

Product NDC
61919-901
11-digit product format
619190901
Labeler code
61919
Product ID
61919-901_f2161bad-5b5a-23d4-e053-2a95a90a801f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077797
Marketing category
ANDA
Marketing start
2019-08-15
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
2024-12-31
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
61919-901-152025-01-30C16284748780-1ba0f9c33-1f0a-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HYDROCHLORIDE
61919-901-202025-01-30C16284748780-1ba0f9c33-50d5-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HCI
61919-901-302025-01-30C16284748780-1ba0f9c33-4395-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HCI
61919-901-452025-01-30C16284748780-1ba0f9c33-4395-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HCI
61919-901-602025-01-30C16284748780-1ba0f9c33-1f0a-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HYDROCHLORIDE
61919-901-822025-01-30C16284748780-1ba0f9c33-4395-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HCI
61919-901-902025-01-30C16284748780-1ba0f9c33-1f0a-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HYDROCHLORIDE
61919-901-152022-10-19C16284748780-1ba0f9c33-1f0a-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HYDROCHLORIDE
61919-901-202022-10-19C16284748780-1ba0f9c33-50d5-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HCI
61919-901-302022-10-19C16284748780-1ba0f9c33-4395-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HCI
61919-901-602022-10-19C16284748780-1ba0f9c33-1f0a-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HYDROCHLORIDE
61919-901-902022-10-19C16284748780-1ba0f9c33-1f0a-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-901-30CYCLOBENZAPRINE HCL30 in 1 BOTTLETABLET, FILM COATED3012
61919-901-45CYCLOBENZAPRINE HCL45 in 1 BOTTLETABLET, FILM COATED4512
61919-901-82CYCLOBENZAPRINE HCL180 in 1 BOTTLETABLET, FILM COATED18012
61919-901-15CYCLOBENZAPRINE HCL15 in 1 BOTTLETABLET, FILM COATED154
61919-901-60CYCLOBENZAPRINE HCL60 in 1 BOTTLETABLET, FILM COATED604
61919-901-90CYCLOBENZAPRINE HCL90 in 1 BOTTLETABLET, FILM COATED904
61919-901-20CYCLOBENZAPRINE HCL20 in 1 BOTTLETABLET, FILM COATED202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-901-15EA - Each61919-901ff01a7c6-a6b0-4198-b1e7-df815cbd7e0212019-10-07
61919-901-20EA - Each61919-901830014a5-5e6b-4383-b86f-4c8ca089562a12019-10-07
61919-901-30EA - Each61919-9013ddd28cb-25d9-4c64-8d83-535f4f7142f112019-04-11
61919-901-60EA - Each61919-9016b34454a-85a6-490e-bc8e-7dba2c24f4d412019-11-12
61919-901-82EA - Each61919-90101238c1c-5ae1-405f-9c78-c801f6db553212023-04-07
61919-901-90EA - Each61919-9011f8695ae-7caa-4422-891d-b17b0d999ffe12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-901CYCLOBENZAPRINE HCI TABLET, FILM COATED CYCLOBENZAPRINE HCL TABLET, FILM COATED [DIRECTRX]12Legacy NDC, 3 package rows20230608_858d10e7-dfe5-4c4f-e053-2a91aa0a783e.zip
61919-901CYCLOBENZAPRINE HCL TABLET, FILM COATED [DIRECT_RX]4Legacy NDC, 3 package rows20230330_93c9f889-a0ef-7cee-e053-2a95a90a1e06.zip
61919-901CYCLOBENZAPRINE HCL TABLET, FILM COATED [DIRECT_RX]2Legacy NDC, 1 package rows20230113_9029367e-7037-2eb2-e053-2a95a90a55b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN858d10e7-dfe5-4c4f-e053-2a91aa0a783e12
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN858d10e7-dfe5-4c4f-e053-2a91aa0a783e12
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD858d10e7-dfe5-4c4f-e053-2a91aa0a783e12
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD858d10e7-dfe5-4c4f-e053-2a91aa0a783e12
828320cyclobenzaprine HCl 5 MG Oral TabletPSN93c9f889-a0ef-7cee-e053-2a95a90a1e064
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD93c9f889-a0ef-7cee-e053-2a95a90a1e064
828320cyclobenzaprine HCl 5 MG Oral TabletPSN9029367e-7037-2eb2-e053-2a95a90a55b72
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD9029367e-7037-2eb2-e053-2a95a90a55b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-901-156191909011515 TABLET, FILM COATED in 1 BOTTLE (61919-901-15) 2019-09-300000-00-00NoNoCurrent
61919-901-206191909012020 TABLET, FILM COATED in 1 BOTTLE (61919-901-20) 2019-08-150000-00-00NoNoCurrent
61919-901-306191909013030 TABLET, FILM COATED in 1 BOTTLE (61919-901-30) 2019-04-040000-00-00NoNoCurrent
61919-901-456191909014545 TABLET, FILM COATED in 1 BOTTLE (61919-901-45) 2019-04-040000-00-00NoNoCurrent
61919-901-606191909016060 TABLET, FILM COATED in 1 BOTTLE (61919-901-60) 2019-09-300000-00-00NoNoCurrent
61919-901-8261919090182180 in 1 BOTTLEHistorical
61919-901-906191909019090 TABLET, FILM COATED in 1 BOTTLE (61919-901-90) 2019-09-300000-00-00NoNoCurrent