Amitriptyline Hydrochloride

Product NDC
16714-448
11-digit product format
167140448
Labeler code
16714
Product ID
16714-448_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
50 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
16714-448-01EA - Each16714-448619ed9b2-6a06-4dcd-b313-84cf769a2feb12015-01-05
16714-448-02EA - Each16714-44882676968-4930-4dfa-899b-985f7c776a5712015-01-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-448-0116714044801100 TABLET, FILM COATED in 1 BOTTLE (16714-448-01) 2014-12-010000-00-00NoNoCurrent
16714-448-02167140448021000 TABLET, FILM COATED in 1 BOTTLE (16714-448-02) 2014-12-010000-00-00NoNoCurrent