FDA.reportPublic FDA data

Imipramine Hydrochloride

Product NDC
69315-134
11-digit product format
693150134
Labeler code
69315
Product ID
69315-134_2fbbe85e-9a5e-45af-bea7-e2b7ef240d3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA040903
Marketing category
ANDA
Marketing start
2016-04-07
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Imipramine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMIPRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBKE5Q1J60U
Rxcui835564, 835568, 835593

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
69315-134-01Imipramine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10019
69315-134-10Imipramine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-134-01EA - Each69315-134c8ec02a2-77c2-481d-996a-29984957494212016-05-16
69315-134-10EA - Each69315-1343718de7c-aea6-439a-90c7-a19e4691257012016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-134IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LEADING PHARMA, LLC]16Current NDC, Legacy NDC, 2 package rows20250331_490263ce-b4d2-428a-87da-fcd07f85499a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835593imipramine HCl 10 MG Oral TabletPSN490263ce-b4d2-428a-87da-fcd07f85499a19
835564imipramine HCl 25 MG Oral TabletPSN490263ce-b4d2-428a-87da-fcd07f85499a19
835564imipramine HCl 25 MG Oral TabletPSN649837df-147f-436c-9553-32ffecf4c6f119
835568imipramine HCl 50 MG Oral TabletPSN490263ce-b4d2-428a-87da-fcd07f85499a19
835593imipramine hydrochloride 10 MG Oral TabletSCD490263ce-b4d2-428a-87da-fcd07f85499a19
835564imipramine hydrochloride 25 MG Oral TabletSCD490263ce-b4d2-428a-87da-fcd07f85499a19
835564imipramine hydrochloride 25 MG Oral TabletSCD649837df-147f-436c-9553-32ffecf4c6f119
835568imipramine hydrochloride 50 MG Oral TabletSCD490263ce-b4d2-428a-87da-fcd07f85499a19
835564imipramine HCl 25 MG Oral TabletPSNd9dbcebe-9aba-4a93-a7b7-48d29e07d3c49
835564imipramine hydrochloride 25 MG Oral TabletSCDd9dbcebe-9aba-4a93-a7b7-48d29e07d3c49
835564imipramine HCl 25 MG Oral TabletPSN20af582f-08ba-4281-a2df-0bcf68c585941
835564imipramine HCl 25 MG Oral TabletPSN48e8b819-a9a0-aa5a-e063-6394a90ad9c21
835564imipramine hydrochloride 25 MG Oral TabletSCD20af582f-08ba-4281-a2df-0bcf68c585941
835564imipramine hydrochloride 25 MG Oral TabletSCD48e8b819-a9a0-aa5a-e063-6394a90ad9c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69315-134-0169315013401100 TABLET, FILM COATED in 1 BOTTLE (69315-134-01) 2016-04-120000-00-00NoNoCurrent
69315-134-10693150134101000 TABLET, FILM COATED in 1 BOTTLE (69315-134-10) 2016-05-010000-00-00NoNoCurrent