Imipramine Hydrochloride

Product NDC
67046-1564
11-digit product format
670461564
Labeler code
67046
Product ID
67046-1564_48e8b30a-0294-a5ed-e063-6394a90a8f01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA040903
Marketing category
ANDA
Marketing start
2026-01-21
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
25 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 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
67046-1564-3Imipramine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835564imipramine HCl 25 MG Oral TabletPSN48e8b819-a9a0-aa5a-e063-6394a90ad9c21
835564imipramine hydrochloride 25 MG Oral TabletSCD48e8b819-a9a0-aa5a-e063-6394a90ad9c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1564-36704615640330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1564-3) 2026-01-21NoNoHistorical