Protriptyline hydrochloride

Product NDC
50383-960
11-digit product format
503830960
Labeler code
50383
Product ID
50383-960_df490f7b-6f10-48dc-9bd9-162746fd8f76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Protriptyline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Hi-Tech Pharmacal Co., Inc.
Application
ANDA202220
Marketing category
ANDA
Marketing start
2013-10-28
Marketing end
0000-00-00
Substance
PROTRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-960-10EA - Each50383-96024e10bbf-8351-4b57-9851-97281acee6ca12013-12-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50383-960-1050383096010100 TABLET, FILM COATED in 1 BOTTLE (50383-960-10) 2013-10-280000-00-00NoNoCurrent