Amitriptyline Hydrochloride

Product NDC: 0904-0201
11-digit product format: 009040201
Labeler code: 0904
Product ID: 0904-0201_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: 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
NDC	Effective	Action	Document	Indexing SPL	Related label
0904-0201-61	2022-08-12	C162847	48780-1	e4f33bdf-a047-d8a0-e053-dadaa90a6e4e	ace47577-12a5-40c8-8c2e-786aa8654cde
0904-0201-61	2022-07-29	C162847	48780-1	e4f33bdf-a047-d8a0-e053-dadaa90a6e4e	ace47577-12a5-40c8-8c2e-786aa8654cde

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-0201-61	EA - Each	0904-0201	5f25ca57-6b70-4083-a413-6a84c497b976	1	2012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-0201-61	00904020161	100 BLISTER PACK in 1 CARTON (0904-0201-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK	100 blister pack	2009-06-10	0000-00-00	No	No	Current