FDA.reportPublic FDA data

Imipramine Hydrochloride

Product NDC
72789-244
11-digit product format
727890244
Labeler code
72789
Product ID
72789-244_4d50ea03-67e1-10a9-e063-6394a90ae03c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040751
Marketing category
ANDA
Marketing start
2020-08-01
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
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
72789-244-01Imipramine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10011
72789-244-95Imipramine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET100011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-244IMIPRAMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20241011_830cb1cb-20a1-4617-a748-24241257a244.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835593imipramine HCl 10 MG Oral TabletPSN830cb1cb-20a1-4617-a748-24241257a24411
835564imipramine HCl 25 MG Oral TabletPSN830cb1cb-20a1-4617-a748-24241257a24411
835568imipramine HCl 50 MG Oral TabletPSN830cb1cb-20a1-4617-a748-24241257a24411
835593imipramine hydrochloride 10 MG Oral TabletSCD830cb1cb-20a1-4617-a748-24241257a24411
835564imipramine hydrochloride 25 MG Oral TabletSCD830cb1cb-20a1-4617-a748-24241257a24411
835568imipramine hydrochloride 50 MG Oral TabletSCD830cb1cb-20a1-4617-a748-24241257a24411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-244-0172789024401100 TABLET in 1 BOTTLE, PLASTIC (72789-244-01) 100 tablet2022-04-140000-00-00NoNoCurrent
72789-244-95727890244951000 TABLET in 1 BOTTLE, PLASTIC (72789-244-95) 1000 tablet2022-11-280000-00-00NoNoCurrent