Cyclobenzaprine Hydrochloride

Product NDC
0591-3330
11-digit product format
005913330
Labeler code
0591
Product ID
0591-3330_015c8193-79db-4eee-9a44-883138b5ee5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA071611
Marketing category
ANDA
Marketing start
2006-02-03
Marketing end
2023-08-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3330-01EA - Each0591-33301edad8c8-ec90-4e7a-b0f1-fe51f7c6cab512016-09-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3330-0100591333001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3330-01) 2006-02-032023-08-31NoNoCurrent