Cyclobenzaprine Hydrochloride

Product NDC
42708-081
11-digit product format
427080081
Labeler code
42708
Product ID
42708-081_bbb3f229-a648-3aba-e053-2995a90a5d99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma Inc
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42708-081-202021-03-12C16284748780-1ba0f9c33-1afc-a910-e053-dadaa90a0b85a1cab16c-50f3-4be6-8453-98f67fb02fa5
42708-081-202021-01-29C16284748780-1ba0f9c33-1afc-a910-e053-dadaa90a0b85a1cab16c-50f3-4be6-8453-98f67fb02fa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-081-204270800812020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-081-20) 2019-03-050000-00-00YesNoCurrent