AMITRIPTYLINE HYDROCHLORIDE

Product NDC
55700-643
11-digit product format
557000643
Labeler code
55700
Product ID
55700-643_1af9bb31-c636-416c-92e2-ed5f70542972
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA202446
Marketing category
ANDA
Marketing start
2018-06-22
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [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
55700-643-30EA - Each55700-643c54176af-5882-4b33-862b-a4d06167c30412018-08-13
55700-643-90EA - Each55700-64329f853c7-c9b1-4659-8bd9-fb8c2a8beb6b12018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-643-305570006433030 TABLET, FILM COATED in 1 BOTTLE (55700-643-30) 2018-06-220000-00-00NoNoCurrent
55700-643-905570006439090 TABLET, FILM COATED in 1 BOTTLE (55700-643-90) 2018-06-220000-00-00NoNoCurrent