Cyclobenzaprine Hydrochloride

Product NDC
0378-0771
11-digit product format
003780771
Labeler code
0378
Product ID
0378-0771_30da9ca4-3bd1-4088-98ba-7e289ffc76be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA073144
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
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
0378-0771-01EA - Each0378-077123f9c17b-806d-4df8-a030-bc1216b8e18712012-07-24
0378-0771-05EA - Each0378-07719a85c97b-c8cf-4a7e-a275-19d614ea220912012-07-24
0378-0771-93EA - Each0378-0771bb9918b6-a724-46d0-a7d8-973d523a29f912012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0771-0100378077101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0771-01) 2006-02-030000-00-00NoNoCurrent