Amitriptyline Hydrochloride

Product NDC
0378-2650
11-digit product format
003782650
Labeler code
0378
Product ID
0378-2650_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
50 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5006e90-7f2e-4341-bcdb-f83027a8fc39Product name620240611
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-2650-01EA - Each0378-26503a569b48-7c67-4437-a7bb-629692b547a412012-07-24
0378-2650-10EA - Each0378-26505dbe4b29-cbd9-418f-828b-83537d9db21f12012-07-24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN2868cad2-19c7-49bf-92d5-52094a782ec55
856845amitriptyline hydrochloride 50 MG Oral TabletSCD2868cad2-19c7-49bf-92d5-52094a782ec55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-2650-0100378265001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2650-01) 1978-04-260000-00-00NoNoCurrent
0378-2650-10003782650101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2650-10) 1978-04-260000-00-00NoNoCurrent