FDA.reportPublic FDA data

Imipramine Hydrochloride

Product NDC
69584-425
11-digit product format
695840425
Labeler code
69584
Product ID
69584-425_1509ebac-0e7d-4b02-ba2e-bf188a26fd77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Oxford Pharmaceuticals, LLC
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
69584-425-10Imipramine Hydrochloride100 in 1 BOTTLETABLET1006
69584-425-90Imipramine Hydrochloride1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-425-10EA - Each69584-4257eefd159-8623-4d08-aab2-ebab81fc4aa212020-08-06
69584-425-90EA - Each69584-42571eb0b40-9080-46bb-81f1-85d308a8015812022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-425IMIPRAMINE HYDROCHLORIDE TABLET [OXFORD PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20220608_a5f60cf1-6f14-40a3-a794-9d69b28088d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835593imipramine HCl 10 MG Oral TabletPSN830cb1cb-20a1-4617-a748-24241257a24411
835564imipramine HCl 25 MG Oral TabletPSN830cb1cb-20a1-4617-a748-24241257a24411
835568imipramine HCl 50 MG Oral TabletPSN830cb1cb-20a1-4617-a748-24241257a24411
835593imipramine hydrochloride 10 MG Oral TabletSCD830cb1cb-20a1-4617-a748-24241257a24411
835564imipramine hydrochloride 25 MG Oral TabletSCD830cb1cb-20a1-4617-a748-24241257a24411
835568imipramine hydrochloride 50 MG Oral TabletSCD830cb1cb-20a1-4617-a748-24241257a24411
835593imipramine HCl 10 MG Oral TabletPSNa5f60cf1-6f14-40a3-a794-9d69b28088d86
835564imipramine HCl 25 MG Oral TabletPSNa5f60cf1-6f14-40a3-a794-9d69b28088d86
835568imipramine HCl 50 MG Oral TabletPSNa5f60cf1-6f14-40a3-a794-9d69b28088d86
835593imipramine hydrochloride 10 MG Oral TabletSCDa5f60cf1-6f14-40a3-a794-9d69b28088d86
835564imipramine hydrochloride 25 MG Oral TabletSCDa5f60cf1-6f14-40a3-a794-9d69b28088d86
835568imipramine hydrochloride 50 MG Oral TabletSCDa5f60cf1-6f14-40a3-a794-9d69b28088d86
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 startMarketing endSampleExclude flagStatus
69584-425-1069584042510100 TABLET in 1 BOTTLE (69584-425-10) 100 tablet2020-08-010000-00-00NoNoCurrent
69584-425-90695840425901000 TABLET in 1 BOTTLE (69584-425-90) 1000 tablet2022-05-150000-00-00NoNoCurrent