Amitriptyline Hydrochloride

Product NDC
0904-0202
11-digit product format
009040202
Labeler code
0904
Product ID
0904-0202_2c82268e-1a92-4551-a3dd-5f5cdefee692
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA085968
Marketing category
ANDA
Marketing start
2009-06-10
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
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
0904-0202-61EA - Each0904-02023be0b48f-07a7-4eb1-ab9d-5b487f4adb8512012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-0202-6100904020261100 BLISTER PACK in 1 CARTON (0904-0202-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2009-06-100000-00-00NoNoCurrent