CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
61919-064
11-digit product format
619190064
Labeler code
61919
Product ID
61919-064_9c93515f-e62c-4c57-e053-2995a90aba82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090478
Marketing category
ANDA
Marketing start
2016-11-16
Marketing end
0000-00-00
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
2021-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-064-20CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED203
61919-064-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED303
61919-064-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED603
61919-064-72CYCLOBENZAPRINE HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1203
61919-064-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-064-20EA - Each61919-064e79bf39f-6b7e-43c7-831b-364e33184c4712016-12-07
61919-064-30EA - Each61919-0642af80e31-a0ff-463a-95b0-d00e0e6cdc7712016-12-07
61919-064-60EA - Each61919-064f3f46701-f914-4a45-96e2-0a2e60d9133212016-12-07
61919-064-72EA - Each61919-06497ac7751-c06c-47bc-a746-66927840d31d12016-12-07
61919-064-90EA - Each61919-064970498a7-bb82-4c28-9b79-118cb4e50db112016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-064CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 5 package rows20200130_41709710-5397-3119-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN41709710-5397-3119-e054-00144ff88e883
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD41709710-5397-3119-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-064-206191900642020 TABLET, FILM COATED in 1 BOTTLE (61919-064-20) 2016-11-160000-00-00NoNoCurrent
61919-064-306191900643030 TABLET, FILM COATED in 1 BOTTLE (61919-064-30) 2016-11-160000-00-00NoNoCurrent
61919-064-606191900646060 TABLET, FILM COATED in 1 BOTTLE (61919-064-60) 2016-11-160000-00-00NoNoCurrent
61919-064-7261919006472120 TABLET, FILM COATED in 1 BOTTLE (61919-064-72) 2016-11-160000-00-00NoNoCurrent
61919-064-906191900649090 TABLET, FILM COATED in 1 BOTTLE (61919-064-90) 2016-11-160000-00-00NoNoCurrent