Amitriptyline Hydrochloride

Product NDC
68071-4238
11-digit product format
680714238
Labeler code
68071
Product ID
68071-4238_d5cb3333-a783-01b4-e053-2995a90a3927
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA085968
Marketing category
ANDA
Marketing start
1977-11-29
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4238-32020-10-12C16284748780-19d75b9d0-c112-f424-e053-dadaa90a57ce63145927-4052-39c1-e053-2a91aa0a72dc
68071-4238-32020-01-31C16284748780-19d75b9d0-c112-f424-e053-dadaa90a57ce63145927-4052-39c1-e053-2a91aa0a72dc

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4238-36807142380330 TABLET, FILM COATED in 1 BOTTLE (68071-4238-3) 2018-01-180000-00-00NoNoCurrent