FDA.reportPublic FDA data

Imipramine Hydrochloride

Product NDC
80425-0342
11-digit product format
804250342
Labeler code
80425
Product ID
80425-0342_2a9c2eb6-a6db-f647-e063-6294a90a93fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA040751
Marketing category
ANDA
Marketing start
2023-06-06
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

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
80425-0342-1Imipramine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
80425-0342-2Imipramine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
80425-0342-3Imipramine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0342-1EA - Each80425-0342dde2fdcb-29e6-40f6-b1e2-91340726269f12023-07-06
80425-0342-2EA - Each80425-0342a1752b69-50a9-4892-96b0-0ce0af54dca312023-07-06
80425-0342-3EA - Each80425-03423b7893e8-a32e-476d-b314-daff78ea369712023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0342IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]4Current NDC, 3 package rows20250102_fd78fb8e-99ae-91b0-e053-6394a90a9271.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835564imipramine HCl 25 MG Oral TabletPSNfd78fb8e-99ae-91b0-e053-6394a90a92714
835564imipramine hydrochloride 25 MG Oral TabletSCDfd78fb8e-99ae-91b0-e053-6394a90a92714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0342-18042503420130 TABLET, FILM COATED in 1 BOTTLE (80425-0342-1) 2023-06-06NoNoCurrent
80425-0342-28042503420260 TABLET, FILM COATED in 1 BOTTLE (80425-0342-2) 2023-06-06NoNoCurrent
80425-0342-38042503420390 TABLET, FILM COATED in 1 BOTTLE (80425-0342-3) 2023-06-06NoNoCurrent