DESIPRAMINE HYDROCHLORIDE

Product NDC
46708-319
11-digit product format
467080319
Labeler code
46708
Product ID
46708-319_878a2586-20af-4f35-8908-82474cc732a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESIPRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA209785
Marketing category
ANDA
Marketing start
2021-07-08
Substance
DESIPRAMINE HYDROCHLORIDE
Active strength
100 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
DESIPRAMINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESIPRAMINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y58DO4MY1
Rxcui1099288, 1099292, 1099296, 1099300, 1099304, 1099316

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bda46dda-4ebd-3e63-0043-123c9d173af2Product name620220125

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-319-30DESIPRAMINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302
46708-319-31DESIPRAMINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1002
46708-319-91DESIPRAMINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-319DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 3 package rows20230202_8b6d2289-aac9-4007-a73d-c168fd2e1d9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099288desipramine HCl 10 MG Oral TabletPSN8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099292desipramine HCl 100 MG Oral TabletPSN8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099296desipramine HCl 150 MG Oral TabletPSN8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099300desipramine HCl 25 MG Oral TabletPSN8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099304desipramine HCl 50 MG Oral TabletPSN8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099316desipramine HCl 75 MG Oral TabletPSN8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099288desipramine hydrochloride 10 MG Oral TabletSCD8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099292desipramine hydrochloride 100 MG Oral TabletSCD8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099296desipramine hydrochloride 150 MG Oral TabletSCD8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099300desipramine hydrochloride 25 MG Oral TabletSCD8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099304desipramine hydrochloride 50 MG Oral TabletSCD8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099316desipramine hydrochloride 75 MG Oral TabletSCD8b6d2289-aac9-4007-a73d-c168fd2e1d9e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-319-304670803193030 TABLET, FILM COATED in 1 BOTTLE (46708-319-30) 2021-07-080000-00-00NoNoCurrent
46708-319-3146708031931100 TABLET, FILM COATED in 1 BOTTLE (46708-319-31) 2021-07-080000-00-00NoNoCurrent
46708-319-91467080319911000 TABLET, FILM COATED in 1 BOTTLE (46708-319-91) 2021-07-080000-00-00NoNoCurrent