Amitriptyline Hydrochloride

Product NDC
63629-2123
11-digit product format
636292123
Labeler code
63629
Product ID
63629-2123_3154e215-429f-41b2-9700-19f4ec4a5987
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-2123-12024-09-30C16284748780-11030e365-6e44-111a-e063-dadaa90a10e27ac319d9-3ec6-4acc-a2cb-7e54406fc423
63629-2123-12024-01-30C16284748780-11030e365-6e44-111a-e063-dadaa90a10e27ac319d9-3ec6-4acc-a2cb-7e54406fc423

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2123-1EA - Each63629-212310dadce4-3e3d-4b1e-8092-cecb5f3241da12021-05-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2123-163629212301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-2123-1) 2021-03-100000-00-00NoNoCurrent