Amitriptyline Hydrochloride

Product NDC
63629-2120
11-digit product format
636292120
Labeler code
63629
Product ID
63629-2120_4d7d9fbb-79d7-4268-aaa2-f57415759ef6
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
25 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
63629-2120-12024-10-01C16284748780-11030e365-476e-111a-e063-dadaa90a10e2277a7b8e-104d-43d0-a9b3-82b3fc17c0da
63629-2120-12024-01-30C16284748780-11030e365-476e-111a-e063-dadaa90a10e2277a7b8e-104d-43d0-a9b3-82b3fc17c0da

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2120-1EA - Each63629-2120d44d9760-7f7d-4194-8c98-86ce887c286f12021-05-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2120-1636292120011000 TABLET, FILM COATED in 1 BOTTLE (63629-2120-1) 2021-02-010000-00-00NoNoCurrent