Amitriptyline Hydrochloride

Product NDC
63629-8987
11-digit product format
636298987
Labeler code
63629
Product ID
63629-8987_08ec7034-241e-482e-973f-29d3e255b7da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040218
Marketing category
ANDA
Marketing start
1997-09-11
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8987-1EA - Each63629-8987492ff946-a2bd-4691-af13-327684c6269012022-03-09
63629-8987-2EA - Each63629-89878d5c1b2d-09fe-4264-bb84-4d70c84a72e912022-03-09
63629-8987-3EA - Each63629-8987633e13e1-930c-4108-b358-9815df82c2c112022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8987AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Legacy NDC20211212_be7c1874-107f-49d4-984b-eef7ec084241.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8987-16362989870130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-8987-1) 2021-12-070000-00-00NoNoCurrent
63629-8987-26362989870260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-8987-2) 2021-12-070000-00-00NoNoCurrent
63629-8987-36362989870390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-8987-3) 2021-12-070000-00-00NoNoCurrent