Cyclobenzaprine Hydrochloride

Product NDC
50090-5897
11-digit product format
500905897
Labeler code
50090
Product ID
50090-5897_c1b7114d-e7c0-4b11-93e5-6b434e6c1c49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA071611
Marketing category
ANDA
Marketing start
2021-07-20
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5897-0EA - Each50090-5897f6614725-39c1-438d-91e9-5f614dec80ab12022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5897-05009058970090 TABLET, FILM COATED in 1 BOTTLE (50090-5897-0) 2022-01-130000-00-00NoNoCurrent