FDA.reportPublic FDA data

Imipramine Hydrochloride

Product NDC
71335-3106
11-digit product format
713353106
Labeler code
71335
Product ID
71335-3106_baeca134-915e-4cfc-93b6-468bd93ff1ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040903
Marketing category
ANDA
Marketing start
2016-04-07
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Imipramine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMIPRAMINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBKE5Q1J60U
Rxcui835593

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3106-1Imipramine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
71335-3106-2Imipramine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835593imipramine HCl 10 MG Oral TabletPSNbcd3b62a-88d4-49eb-b0aa-71e28cf409191
835593imipramine hydrochloride 10 MG Oral TabletSCDbcd3b62a-88d4-49eb-b0aa-71e28cf409191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3106-17133531060130 TABLET, FILM COATED in 1 BOTTLE (71335-3106-1) 2026-03-16NoNoHistorical
71335-3106-271335310602100 TABLET, FILM COATED in 1 BOTTLE (71335-3106-2) 2026-03-16NoNoHistorical