FDA.reportPublic FDA data

Imipramine hydrochloride

Product NDC
80425-0294
11-digit product format
804250294
Labeler code
80425
Product ID
80425-0294_2a9bad62-b304-697c-e063-6294a90aa395
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA040903
Marketing category
ANDA
Marketing start
2023-04-04
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
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
80425-0294-1Imipramine hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
80425-0294-2Imipramine hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
80425-0294-3Imipramine hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0294-1EA - Each80425-02940ec4b13f-39d3-4b14-ae64-736e80b4dc0e12023-06-06
80425-0294-2EA - Each80425-02945e9beb98-7776-416b-959c-c020cd32e08812023-06-06
80425-0294-3EA - Each80425-0294ab97ad20-b758-4468-8eb2-55d933bc111c12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0294IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f887062a-7c82-664f-e053-6294a90a2773.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835593imipramine HCl 10 MG Oral TabletPSNf887062a-7c82-664f-e053-6294a90a27732
835593imipramine hydrochloride 10 MG Oral TabletSCDf887062a-7c82-664f-e053-6294a90a27732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0294-18042502940130 TABLET, FILM COATED in 1 BOTTLE (80425-0294-1) 2023-04-04NoNoCurrent
80425-0294-28042502940260 TABLET, FILM COATED in 1 BOTTLE (80425-0294-2) 2023-04-04NoNoCurrent
80425-0294-38042502940390 TABLET, FILM COATED in 1 BOTTLE (80425-0294-3) 2023-04-04NoNoCurrent