Amitriptyline Hydrochloride

Product NDC
16714-446
11-digit product format
167140446
Labeler code
16714
Product ID
16714-446_16aa3a63-b0fc-44a5-8591-e0749ac800ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northstar RxLLC
Application
ANDA085968
Marketing category
ANDA
Marketing start
2014-12-01
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-446-01EA - Each16714-446dfabcbe0-5694-4d7e-a633-68926198ecd212015-01-05
16714-446-02EA - Each16714-446f0d89c81-4010-4984-9bc3-5ca14363104c12015-01-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-446-0116714044601100 TABLET, FILM COATED in 1 BOTTLE (16714-446-01) 2014-12-010000-00-00NoNoCurrent
16714-446-02167140446021000 TABLET, FILM COATED in 1 BOTTLE (16714-446-02) 2014-12-010000-00-00NoNoCurrent