Cyclobenzaprine Hydrochloride

Product NDC
55700-599
11-digit product format
557000599
Labeler code
55700
Product ID
55700-599_65c3ce57-7d5a-4f61-aa27-e8a731301172
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA077797
Marketing category
ANDA
Marketing start
2018-04-13
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-599-10EA - Each55700-599c7838130-d20b-4c8b-ae8c-82201c1eb90012018-12-13
55700-599-15EA - Each55700-5995e5c4f67-c33b-427c-885f-288fde66687012018-05-09
55700-599-20EA - Each55700-59907e3ffe7-a9e4-4732-942e-5429a02b866312018-05-09
55700-599-21EA - Each55700-5993f5227cd-4f8a-414b-9563-43c07344040f12018-05-09
55700-599-30EA - Each55700-5995a51ae2c-a9c8-4213-a430-32f1914e952c12018-05-09
55700-599-60EA - Each55700-5998c26de67-1c8b-4c88-865a-b8e9774034d212018-05-09
55700-599-90EA - Each55700-5999613e625-7f76-42b0-8c80-f0c7969677b012018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-599-105570005991010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-599-10) 2018-10-260000-00-00NoNoCurrent
55700-599-155570005991515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-599-15) 2018-04-130000-00-00NoNoCurrent
55700-599-205570005992020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-599-20) 2018-04-130000-00-00NoNoCurrent
55700-599-215570005992121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-599-21) 2018-04-130000-00-00NoNoCurrent
55700-599-305570005993030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-599-30) 2018-04-130000-00-00NoNoCurrent
55700-599-605570005996060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-599-60) 2018-04-130000-00-00NoNoCurrent
55700-599-905570005999090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-599-90) 2018-04-130000-00-00NoNoCurrent