Amitriptyline Hydrochloride

Product NDC
16714-450
11-digit product format
167140450
Labeler code
16714
Product ID
16714-450_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
100 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16714-450-012020-08-18C16284748780-1ab0e2407-319c-f274-e053-dbdaa90a647123521590-ec42-4845-aab4-600f6b79e084
16714-450-012020-07-22C16284748780-1ab0e2407-319c-f274-e053-dbdaa90a647123521590-ec42-4845-aab4-600f6b79e084

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-450-01EA - Each16714-450f713dda5-92cf-450c-9e24-77bf37fb6deb12015-01-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-450-0116714045001100 TABLET, FILM COATED in 1 BOTTLE (16714-450-01) 2014-12-010000-00-00NoNoCurrent