FDA.reportPublic FDA data

Imipramine Hydrochloride

Product NDC
72789-493
11-digit product format
727890493
Labeler code
72789
Product ID
72789-493_4e0451aa-af58-5f2e-e063-6294a90aa3ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040903
Marketing category
ANDA
Marketing start
2016-04-07
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBKE5Q1J60U
Rxcui835568

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
72789-493-01Imipramine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10019
72789-493-95Imipramine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-493-01EA - Each72789-4934a795349-4f00-4b65-809b-77b04c7a46a912025-10-14
72789-493-95EA - Each72789-493418d789c-9029-4182-97ab-d65836fd877512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-493IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16Current NDC, 2 package rows20250312_7091ff32-55b9-48fd-a86d-c502af57473f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835568imipramine HCl 50 MG Oral TabletPSN7091ff32-55b9-48fd-a86d-c502af57473f19
835568imipramine hydrochloride 50 MG Oral TabletSCD7091ff32-55b9-48fd-a86d-c502af57473f19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-493-0172789049301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-493-01) 2025-09-03NoNoHistorical
72789-493-95727890493951000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-493-95) 2025-09-03NoNoHistorical