Amitriptyline Hydrochloride

Product NDC
63629-3597
11-digit product format
636293597
Labeler code
63629
Product ID
63629-3597_46c2a8a1-3f7d-4660-b5d6-73de13b4a060
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA085968
Marketing category
ANDA
Marketing start
1977-11-29
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3597-1EA - Each63629-3597296a8b09-f81c-4e58-b935-2c86019857d412012-07-24
63629-3597-2EA - Each63629-35977e2e880f-0817-480b-92c1-8022c6454c3512012-07-24
63629-3597-3EA - Each63629-35976fbda564-9d60-4c3a-898e-f18c092c6f6f12013-02-13
63629-3597-4EA - Each63629-3597bf6f8f5d-1667-43e4-83d8-4d4e2760d00512013-02-13
63629-3597-5EA - Each63629-35978aa64fc6-5035-4858-9524-2fdce882d7c812022-05-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-3597-16362935970130 TABLET, FILM COATED in 1 BOTTLE (63629-3597-1) 2022-03-300000-00-00NoNoCurrent
63629-3597-263629359702100 TABLET, FILM COATED in 1 BOTTLE (63629-3597-2) 2022-03-300000-00-00NoNoCurrent
63629-3597-36362935970328 TABLET, FILM COATED in 1 BOTTLE (63629-3597-3) 2022-03-300000-00-00NoNoCurrent
63629-3597-46362935970460 TABLET, FILM COATED in 1 BOTTLE (63629-3597-4) 2022-03-300000-00-00NoNoCurrent
63629-3597-56362935970590 TABLET, FILM COATED in 1 BOTTLE (63629-3597-5) 2022-03-300000-00-00NoNoCurrent