FDA.reportPublic FDA data

Imipramine Hydrochloride

Product NDC
82804-956
11-digit product format
828040956
Labeler code
82804
Product ID
82804-956_5997822f-ce83-4091-be71-21a6b01caaba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040751
Marketing category
ANDA
Marketing start
2020-08-01
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
82804-956-00Imipramine Hydrochloride100 in 1 BOTTLETABLET1001
82804-956-11Imipramine Hydrochloride1000 in 1 BOTTLETABLET10001
82804-956-30Imipramine Hydrochloride30 in 1 BOTTLETABLET301
82804-956-55Imipramine Hydrochloride500 in 1 BOTTLETABLET5001
82804-956-60Imipramine Hydrochloride60 in 1 BOTTLETABLET601
82804-956-72Imipramine Hydrochloride120 in 1 BOTTLETABLET1201
82804-956-90Imipramine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835593imipramine HCl 10 MG Oral TabletPSN5997822f-ce83-4091-be71-21a6b01caaba1
835564imipramine HCl 25 MG Oral TabletPSN5997822f-ce83-4091-be71-21a6b01caaba1
835568imipramine HCl 50 MG Oral TabletPSN5997822f-ce83-4091-be71-21a6b01caaba1
835593imipramine hydrochloride 10 MG Oral TabletSCD5997822f-ce83-4091-be71-21a6b01caaba1
835564imipramine hydrochloride 25 MG Oral TabletSCD5997822f-ce83-4091-be71-21a6b01caaba1
835568imipramine hydrochloride 50 MG Oral TabletSCD5997822f-ce83-4091-be71-21a6b01caaba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-956-0082804095600100 TABLET in 1 BOTTLE (82804-956-00) 100 tablet2026-01-12NoNoCurrent
82804-956-11828040956111000 TABLET in 1 BOTTLE (82804-956-11) 1000 tablet2026-01-12NoNoCurrent
82804-956-308280409563030 TABLET in 1 BOTTLE (82804-956-30) 30 tablet2026-01-12NoNoCurrent
82804-956-5582804095655500 TABLET in 1 BOTTLE (82804-956-55) 500 tablet2026-01-12NoNoCurrent
82804-956-608280409566060 TABLET in 1 BOTTLE (82804-956-60) 60 tablet2026-01-12NoNoCurrent
82804-956-7282804095672120 TABLET in 1 BOTTLE (82804-956-72) 120 tablet2026-01-12NoNoCurrent
82804-956-908280409569090 TABLET in 1 BOTTLE (82804-956-90) 90 tablet2026-01-12NoNoCurrent