Amitriptyline Hydrochloride

Product NDC
55289-124
11-digit product format
552890124
Labeler code
55289
Product ID
55289-124_d2313aa0-7b6c-17cc-e053-2995a90a8cfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040218
Marketing category
ANDA
Marketing start
1997-09-11
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-124-12EA - Each55289-1240ce75624-fca1-401e-bad5-256116f4018112012-07-24
55289-124-30EA - Each55289-124e85d6240-aa6a-4f81-b591-faac7e44fd1412012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-124-125528901241212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-124-12) 2010-04-130000-00-00NoNoCurrent
55289-124-305528901243030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-124-30) 2010-04-130000-00-00NoNoCurrent