Amitriptyline Hydrochloride

Product NDC
63629-2116
11-digit product format
636292116
Labeler code
63629
Product ID
63629-2116_961e9eb3-8a76-4e3b-9f0a-b0f8e2a577ae
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
10 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
63629-2116-1EA - Each63629-2116a241c984-ddad-44ed-8c0f-43365c0322c612021-05-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2116-163629211601100 TABLET, FILM COATED in 1 BOTTLE (63629-2116-1) 2021-02-010000-00-00NoNoCurrent