CYCLOBENZAPRINE HCI

Product NDC
61919-681
11-digit product format
619190681
Labeler code
61919
Product ID
61919-681_eada9db9-bce4-5ca9-e053-2a95a90a271c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HCI
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECTRX
Application
ANDA078722
Marketing category
ANDA
Marketing start
2019-04-02
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
8 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-681-30CYCLOBENZAPRINE HCI30 in 1 BOTTLETABLET, FILM COATED3012
61919-681-60CYCLOBENZAPRINE HCI60 in 1 BOTTLETABLET, FILM COATED6012
61919-681-72CYCLOBENZAPRINE HCI72 in 1 BOTTLETABLET, FILM COATED7212
61919-681-90CYCLOBENZAPRINE HCI90 in 1 BOTTLETABLET, FILM COATED9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-681-30EA - Each61919-681b60368c4-ffc4-43b3-8917-5123e448be0312021-11-09
61919-681-60EA - Each61919-681f7d91a82-32b7-4a87-ad00-9a7ce919fa6112022-10-06
61919-681-72EA - Each61919-6814cf999be-925a-4574-8da4-6b06fb49697812022-10-06
61919-681-90EA - Each61919-6811dc91934-f639-4c51-ba60-534f352bd92812019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-681CYCLOBENZAPRINE HCI TABLET, FILM COATED CYCLOBENZAPRINE HCL TABLET, FILM COATED [DIRECTRX]12Legacy NDC, 4 package rows20230608_858d10e7-dfe5-4c4f-e053-2a91aa0a783e.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-681-306191906813030 TABLET, FILM COATED in 1 BOTTLE (61919-681-30) 2019-04-020000-00-00NoNoCurrent
61919-681-606191906816060 TABLET, FILM COATED in 1 BOTTLE (61919-681-60) 2019-04-020000-00-00NoNoCurrent
61919-681-726191906817272 TABLET, FILM COATED in 1 BOTTLE (61919-681-72) 2019-04-020000-00-00NoNoCurrent
61919-681-906191906819090 TABLET, FILM COATED in 1 BOTTLE (61919-681-90) 2019-04-020000-00-00NoNoCurrent