FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
61919-537
11-digit product format
619190537
Labeler code
61919
Product ID
61919-537_ea4ea2fe-af4a-0b3c-e053-2a95a90a0ad5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077797
Marketing category
ANDA
Marketing start
2019-08-14
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
2023-12-31
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
61919-537-902025-01-30C16284748780-12cef2736-aeea-d83d-e063-dadaa90ab31fCYCLOBENZAPRINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-537-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-537-10EA - Each61919-5373e2b5098-263b-4d99-be0a-b85195212c2212019-09-05
61919-537-15EA - Each61919-5371aaf469d-9859-48ff-a61f-e4bc29945b9d12019-09-05
61919-537-20EA - Each61919-5370c2449fb-a3cd-436c-bcec-0611120dd97d12019-09-05
61919-537-21EA - Each61919-537d96022ac-d166-46d5-bf73-f514dc90f32612019-09-05
61919-537-30EA - Each61919-53733bb65e8-6efd-485e-b718-e2772a7dee8212019-09-05
61919-537-60EA - Each61919-5378e6752e3-b8c7-4ced-a5a5-9847f7b310bd12019-09-05
61919-537-86EA - Each61919-5373bc41c31-250f-439e-b7bb-5c6ffe13db5a12019-08-06
61919-537-90EA - Each61919-537f88fef1a-d842-4814-b7bf-cf601f0385c712019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-537CYCLOBENZAPRINE TABLET, FILM COATED CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 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
61919-537-106191905371010 TABLET, FILM COATED in 1 BOTTLE (61919-537-10) 2019-08-160000-00-00NoNoCurrent
61919-537-156191905371515 TABLET, FILM COATED in 1 BOTTLE (61919-537-15) 2019-08-140000-00-00NoNoCurrent
61919-537-206191905372020 TABLET, FILM COATED in 1 BOTTLE (61919-537-20) 2019-08-130000-00-00NoNoCurrent
61919-537-216191905372121 TABLET, FILM COATED in 1 BOTTLE (61919-537-21) 2019-08-230000-00-00NoNoCurrent
61919-537-306191905373030 TABLET, FILM COATED in 1 BOTTLE (61919-537-30) 2019-08-140000-00-00NoNoCurrent
61919-537-606191905376060 TABLET, FILM COATED in 1 BOTTLE (61919-537-60) 2019-08-140000-00-00NoNoCurrent
61919-537-8661919053786270 TABLET, FILM COATED in 1 BOTTLE (61919-537-86) 2019-07-020000-00-00NoNoCurrent
61919-537-906191905379090 TABLET, FILM COATED in 1 BOTTLE (61919-537-90) 2019-04-040000-00-00NoNoCurrent