Cyclobenzaprine Hydrochloride

Product NDC
63187-923
11-digit product format
631870923
Labeler code
63187
Product ID
63187-923_7e7dea0f-3605-4fe0-b204-d46938a16a6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078722
Marketing category
ANDA
Marketing start
2017-08-01
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-923-30EA - Each63187-92317650795-ae51-439f-b682-1ddfec48625912018-05-09
63187-923-60EA - Each63187-923a13a849c-794d-4e56-8eff-6111f414551412017-12-14
63187-923-72EA - Each63187-92300b73add-d57f-4f14-8f03-a6f5a6efb01012018-05-09
63187-923-90EA - Each63187-92390a6fb5c-32c1-47fa-8a98-5f1ce91a317412017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-923CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2Legacy NDC20191108_258db60a-d33d-4da2-ad16-927f6b26c58d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-923-306318709233030 TABLET, FILM COATED in 1 BOTTLE (63187-923-30) 2017-10-020000-00-00NoNoCurrent
63187-923-606318709236060 TABLET, FILM COATED in 1 BOTTLE (63187-923-60) 2017-10-020000-00-00NoNoCurrent
63187-923-7263187092372120 TABLET, FILM COATED in 1 BOTTLE (63187-923-72) 2017-10-020000-00-00NoNoCurrent
63187-923-7863187092378180 TABLET, FILM COATED in 1 BOTTLE (63187-923-78) 2017-10-020000-00-00NoNoCurrent
63187-923-906318709239090 TABLET, FILM COATED in 1 BOTTLE (63187-923-90) 2017-10-020000-00-00NoNoCurrent