Cyclobenzaprine Hydrochloride

Product NDC
70518-0635
11-digit product format
705180635
Labeler code
70518
Product ID
70518-0635_e208f45c-3a70-a7ad-e053-2a95a90acd39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090478
Marketing category
ANDA
Marketing start
2017-07-25
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0635-1705180635015 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0635-1) 2017-08-170000-00-00NoNoCurrent
70518-0635-27051806350220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0635-2) 2017-09-250000-00-00NoNoCurrent
70518-0635-37051806350315 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0635-3) 2018-01-180000-00-00NoNoCurrent
70518-0635-4705180635046 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0635-4) 2018-04-270000-00-00NoNoCurrent
70518-0635-57051806350590 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0635-5) 2018-06-150000-00-00NoNoCurrent
70518-0635-67051806350630 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0635-6) 2018-12-260000-00-00NoNoCurrent
70518-0635-87051806350810 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0635-8) 2020-10-200000-00-00NoNoCurrent
70518-0635-97051806350912 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0635-9) 2021-02-220000-00-00NoNoCurrent