FDA.reportPublic FDA data

Imipramine Hydrochloride

Product NDC
69315-133
11-digit product format
693150133
Labeler code
69315
Product ID
69315-133_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
10 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 HYDROCHLORIDE10 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
69315-133-01Imipramine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10019
69315-133-10Imipramine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-133-01EA - Each69315-133618ee5ca-f2a7-433f-8fbc-89bdf4f68acb12016-05-16
69315-133-10EA - Each69315-133a2c72faa-85a9-4fff-8c3d-44a430ca61b512016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-133IMIPRAMINE 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
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
835568imipramine hydrochloride 50 MG Oral TabletSCD490263ce-b4d2-428a-87da-fcd07f85499a19
835593imipramine HCl 10 MG Oral TabletPSNf887062a-7c82-664f-e053-6294a90a27732
835593imipramine hydrochloride 10 MG Oral TabletSCDf887062a-7c82-664f-e053-6294a90a27732
835593imipramine HCl 10 MG Oral TabletPSN3f90b8dd-7234-4428-b896-943d052dd05f1
835593imipramine HCl 10 MG Oral TabletPSNbcd3b62a-88d4-49eb-b0aa-71e28cf409191
835593imipramine hydrochloride 10 MG Oral TabletSCD3f90b8dd-7234-4428-b896-943d052dd05f1
835593imipramine hydrochloride 10 MG Oral TabletSCDbcd3b62a-88d4-49eb-b0aa-71e28cf409191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69315-133-0169315013301100 TABLET, FILM COATED in 1 BOTTLE (69315-133-01) 2016-04-070000-00-00NoNoCurrent
69315-133-10693150133101000 TABLET, FILM COATED in 1 BOTTLE (69315-133-10) 2016-04-140000-00-00NoNoCurrent