Cyclobenzaprine Hydrochloride

Product NDC
63187-380
11-digit product format
631870380
Labeler code
63187
Product ID
63187-380_53d5b830-11da-4445-b431-c04a4bb6b016
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA071611
Marketing category
ANDA
Marketing start
2006-02-03
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-380-10EA - Each63187-3807ccdee15-9158-47b7-a1b1-c6abe37903f312018-11-06
63187-380-30EA - Each63187-38068cbad65-9830-46db-9837-1f0290e4838b12016-12-07
63187-380-60EA - Each63187-38026c621d8-917f-4b27-86b4-d30b7b42f5c312017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-380CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3Legacy NDC20200219_1a61fff8-8346-472e-9e06-cecbff8c7caa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-380-0063187038000100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-380-00) 2016-09-010000-00-00NoNoCurrent
63187-380-106318703801010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-380-10) 2016-09-010000-00-00NoNoCurrent
63187-380-156318703801515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-380-15) 2016-09-010000-00-00NoNoCurrent
63187-380-206318703802020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-380-20) 2016-09-010000-00-00NoNoCurrent
63187-380-216318703802121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-380-21) 2016-09-010000-00-00NoNoCurrent
63187-380-306318703803030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-380-30) 2016-09-010000-00-00NoNoCurrent
63187-380-456318703804545 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-380-45) 2016-09-010000-00-00NoNoCurrent
63187-380-606318703806060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-380-60) 2016-09-010000-00-00NoNoCurrent
63187-380-7263187038072120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-380-72) 2016-09-010000-00-00NoNoCurrent
63187-380-7863187038078180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-380-78) 2016-09-010000-00-00NoNoCurrent
63187-380-906318703809090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-380-90) 2016-09-010000-00-00NoNoCurrent