FDA.reportPublic FDA data

Imipramine Hydrochloride

Product NDC
82804-957
11-digit product format
828040957
Labeler code
82804
Product ID
82804-957_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
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, 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
82804-957-00Imipramine Hydrochloride100 in 1 BOTTLETABLET1001
82804-957-11Imipramine Hydrochloride1000 in 1 BOTTLETABLET10001
82804-957-30Imipramine Hydrochloride30 in 1 BOTTLETABLET301
82804-957-55Imipramine Hydrochloride500 in 1 BOTTLETABLET5001
82804-957-60Imipramine Hydrochloride60 in 1 BOTTLETABLET601
82804-957-72Imipramine Hydrochloride120 in 1 BOTTLETABLET1201
82804-957-90Imipramine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-957-00EA - Each82804-957e8407b7a-76bb-4da0-a669-8d618f665dd512026-02-05
82804-957-11EA - Each82804-95736ccc94c-79ff-4f2c-b1b9-e657454650b112026-02-05
82804-957-30EA - Each82804-957b1c73f55-b7f1-4dd1-86fd-47b40d9fe4ec12026-02-05
82804-957-55EA - Each82804-95779f1fc9a-4bf1-41f2-b0d3-a4c5263969bb12026-02-05
82804-957-60EA - Each82804-957648d6440-45ab-48d9-953c-b2bba669730312026-02-05
82804-957-72EA - Each82804-95728f7ad88-f606-4e5e-b5ab-3eb0752aeea512026-02-05
82804-957-90EA - Each82804-95797f38aa0-04ed-4165-9d38-b68d339e78af12026-02-05

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
82804-957-0082804095700100 TABLET in 1 BOTTLE (82804-957-00) 100 tablet2026-01-12NoNoHistorical
82804-957-11828040957111000 TABLET in 1 BOTTLE (82804-957-11) 1000 tablet2026-01-12NoNoHistorical
82804-957-308280409573030 TABLET in 1 BOTTLE (82804-957-30) 30 tablet2026-01-12NoNoHistorical
82804-957-5582804095755500 TABLET in 1 BOTTLE (82804-957-55) 500 tablet2026-01-12NoNoHistorical
82804-957-608280409576060 TABLET in 1 BOTTLE (82804-957-60) 60 tablet2026-01-12NoNoHistorical
82804-957-7282804095772120 TABLET in 1 BOTTLE (82804-957-72) 120 tablet2026-01-12NoNoHistorical
82804-957-908280409579090 TABLET in 1 BOTTLE (82804-957-90) 90 tablet2026-01-12NoNoHistorical