FDA.reportPublic FDA data

Imipramine Hydrochloride

Product NDC
50436-2022
11-digit product format
504362022
Labeler code
50436
Product ID
50436-2022_ebfea991-9fd2-46bc-8ff2-aceed31bc3d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040751
Marketing category
ANDA
Marketing start
2022-07-18
Marketing end
0000-00-00
Substance
IMIPRAMINE 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0e0df1b-51aa-4301-873c-732ab0ec1631Product name120170614
0c52f100-e529-4cfc-bd59-334f3eea0233Product name120151110

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-2022-12024-01-30C16284748780-11030e365-2276-111a-e063-dadaa90a10e2IMIPRAMINE HYDROCHLORIDE
50436-2022-22024-01-30C16284748780-11030e365-2276-111a-e063-dadaa90a10e2IMIPRAMINE HYDROCHLORIDE
50436-2022-32024-01-30C16284748780-11030e365-2276-111a-e063-dadaa90a10e2IMIPRAMINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-2022-1Imipramine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
50436-2022-2Imipramine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
50436-2022-3Imipramine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-2022-1EA - Each50436-20228a4531bc-ab76-4543-b70a-092b988b588d12022-08-04
50436-2022-2EA - Each50436-202226c31f00-afb2-4b89-aad0-174fb937288a12022-08-04
50436-2022-3EA - Each50436-2022b49c8352-262d-43e6-a239-46452c37881012022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-2022IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 3 package rows20220803_b59101e9-b513-4c52-8024-1f8bea700210.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835564imipramine HCl 25 MG Oral TabletPSNb59101e9-b513-4c52-8024-1f8bea7002102
835564imipramine hydrochloride 25 MG Oral TabletSCDb59101e9-b513-4c52-8024-1f8bea7002102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-2022-15043620220130 TABLET, FILM COATED in 1 BOTTLE (50436-2022-1) 2022-07-180000-00-00NoNoCurrent
50436-2022-25043620220260 TABLET, FILM COATED in 1 BOTTLE (50436-2022-2) 2022-07-180000-00-00NoNoCurrent
50436-2022-35043620220390 TABLET, FILM COATED in 1 BOTTLE (50436-2022-3) 2022-07-180000-00-00NoNoCurrent