Imipramine Hydrochloride

Product NDC
70868-810
11-digit product format
708680810
Labeler code
70868
Product ID
70868-810_241442d6-33bd-74fe-e063-6394a90a0a49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Key Therapeutics
Application
ANDA040751
Marketing category
ANDA
Marketing start
2022-07-18
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Imipramine Hydrochloride
Listing expiration
2026-12-31

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
70868-810-10Imipramine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70868-810-10EA - Each70868-810481c3e00-4d20-42c5-8764-c8aaaa4dcd7512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70868-810IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [KEY THERAPEUTICS]2Current NDC, Legacy NDC, 1 package rows20241019_9c685c94-64cd-442a-ade7-193c62d7a058.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835564imipramine HCl 25 MG Oral TabletPSNfd78fb8e-99ae-91b0-e053-6394a90a92714
835564imipramine hydrochloride 25 MG Oral TabletSCDfd78fb8e-99ae-91b0-e053-6394a90a92714
835564imipramine HCl 25 MG Oral TabletPSN9c685c94-64cd-442a-ade7-193c62d7a0582
835564imipramine HCl 25 MG Oral TabletPSNb59101e9-b513-4c52-8024-1f8bea7002102
835564imipramine hydrochloride 25 MG Oral TabletSCD9c685c94-64cd-442a-ade7-193c62d7a0582
835564imipramine hydrochloride 25 MG Oral TabletSCDb59101e9-b513-4c52-8024-1f8bea7002102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70868-810-1070868081010100 TABLET, FILM COATED in 1 BOTTLE (70868-810-10) 2022-07-180000-00-00NoNoCurrent