Imipramine Hydrochloride

Product NDC
70518-1588
11-digit product format
705181588
Labeler code
70518
Product ID
70518-1588_494e4586-13e0-bc7a-e063-6294a90a90cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040903
Marketing category
ANDA
Marketing start
2018-10-25
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
70518-1588-0Imipramine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1588IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 1 package rows20250226_db007ac0-020e-4962-8903-7497ab96a74e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835568imipramine HCl 50 MG Oral TabletPSNdb007ac0-020e-4962-8903-7497ab96a74e13
835568imipramine hydrochloride 50 MG Oral TabletSCDdb007ac0-020e-4962-8903-7497ab96a74e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1588-07051815880030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1588-0) 2018-10-250000-00-00NoNoCurrent