FDA.reportPublic FDA data

Imipramine Hydrochloride

Product NDC
82804-958
11-digit product format
828040958
Labeler code
82804
Product ID
82804-958_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
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
82804-958-00Imipramine Hydrochloride100 in 1 BOTTLETABLET1001
82804-958-11Imipramine Hydrochloride1000 in 1 BOTTLETABLET10001
82804-958-30Imipramine Hydrochloride30 in 1 BOTTLETABLET301
82804-958-55Imipramine Hydrochloride500 in 1 BOTTLETABLET5001
82804-958-60Imipramine Hydrochloride60 in 1 BOTTLETABLET601
82804-958-72Imipramine Hydrochloride120 in 1 BOTTLETABLET1201
82804-958-90Imipramine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-958-00EA - Each82804-95806e8d820-3fc2-46b6-b711-8787235e3c6a12026-02-05
82804-958-11EA - Each82804-958d8bb0033-57a6-439f-af27-3f541f313eab12026-02-05
82804-958-30EA - Each82804-9582da3164f-246c-4c04-92ca-6b3ce70b0ec312026-02-05
82804-958-55EA - Each82804-9580e462e2c-3384-4d21-8d08-e3199ff2e51f12026-02-05
82804-958-60EA - Each82804-95868e9f4b0-131b-4ef7-b704-126cf703a7ff12026-02-05
82804-958-72EA - Each82804-95888ae7462-bbff-487c-9cc2-622add0894a812026-02-05
82804-958-90EA - Each82804-958e1d4716b-be34-4587-a283-07e2c5944b7112026-02-05

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
82804-958-0082804095800100 TABLET in 1 BOTTLE (82804-958-00) 100 tablet2026-01-12NoNoCurrent
82804-958-11828040958111000 TABLET in 1 BOTTLE (82804-958-11) 1000 tablet2026-01-12NoNoCurrent
82804-958-308280409583030 TABLET in 1 BOTTLE (82804-958-30) 30 tablet2026-01-12NoNoCurrent
82804-958-5582804095855500 TABLET in 1 BOTTLE (82804-958-55) 500 tablet2026-01-12NoNoCurrent
82804-958-608280409586060 TABLET in 1 BOTTLE (82804-958-60) 60 tablet2026-01-12NoNoCurrent
82804-958-7282804095872120 TABLET in 1 BOTTLE (82804-958-72) 120 tablet2026-01-12NoNoCurrent
82804-958-908280409589090 TABLET in 1 BOTTLE (82804-958-90) 90 tablet2026-01-12NoNoCurrent