Cyclobenzaprine Hydrochloride

Product NDC
60505-3973
11-digit product format
605053973
Labeler code
60505
Product ID
60505-3973_d5ad254d-7c8e-f25b-85d3-07dcbf61fac7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA206703
Marketing category
ANDA
Marketing start
2019-03-01
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
30 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
60505-3973-6EA - Each60505-3973c78b6d31-78ce-4d4d-b75c-c1118d8f041f12019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3973-66050539730660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-3973-6) 2019-03-010000-00-00NoNoCurrent