Amitriptyline Hydrochloride

Product NDC
0378-2695
11-digit product format
003782695
Labeler code
0378
Product ID
0378-2695_253441c9-4d92-42bb-964f-8b19d1dbacfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amitriptyline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA086009
Marketing category
ANDA
Marketing start
1978-04-10
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-2695-01EA - Each0378-2695e9e91026-6b8c-4e65-bc05-415b27088af512012-07-24
0378-2695-93EA - Each0378-26957c245ebf-ee0b-43b9-900d-eb2b46fd306312012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-2695-0100378269501100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2695-01) 1978-04-260000-00-00NoNoCurrent