Imipramine Hydrochloride

Product NDC
68071-3669
11-digit product format
680713669
Labeler code
68071
Product ID
68071-3669_209ca50a-3b5e-3799-e063-6294a90a80e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare 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
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 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
68071-3669-9Imipramine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3669IMIPRAMINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240828_209cc339-658a-577a-e063-6394a90a2b47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835568imipramine HCl 50 MG Oral TabletPSN209cc339-658a-577a-e063-6394a90a2b471
835568imipramine hydrochloride 50 MG Oral TabletSCD209cc339-658a-577a-e063-6394a90a2b471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3669-96807136690990 TABLET in 1 BOTTLE (68071-3669-9) 90 tablet2020-08-01NoNoHistorical