FDA.reportPublic FDA data

DESIPRAMINE HYDROCHLORIDE

Product NDC
62332-320
11-digit product format
623320320
Labeler code
62332
Product ID
62332-320_06c52509-29c8-41c5-8492-3458df75f3d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESIPRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA209785
Marketing category
ANDA
Marketing start
2021-07-08
Substance
DESIPRAMINE HYDROCHLORIDE
Active strength
150 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 HYDROCHLORIDE150 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-320-30DESIPRAMINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED307
62332-320-31DESIPRAMINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1007
62332-320-50DESIPRAMINE HYDROCHLORIDE50 in 1 BOTTLETABLET, FILM COATED507
62332-320-91DESIPRAMINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-320DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 4 package rows20211013_cad14805-64d8-4257-b5f1-d56e0063f0e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099288desipramine HCl 10 MG Oral TabletPSNcad14805-64d8-4257-b5f1-d56e0063f0e27
1099292desipramine HCl 100 MG Oral TabletPSNcad14805-64d8-4257-b5f1-d56e0063f0e27
1099296desipramine HCl 150 MG Oral TabletPSNcad14805-64d8-4257-b5f1-d56e0063f0e27
1099300desipramine HCl 25 MG Oral TabletPSNcad14805-64d8-4257-b5f1-d56e0063f0e27
1099304desipramine HCl 50 MG Oral TabletPSNcad14805-64d8-4257-b5f1-d56e0063f0e27
1099316desipramine HCl 75 MG Oral TabletPSNcad14805-64d8-4257-b5f1-d56e0063f0e27
1099288desipramine hydrochloride 10 MG Oral TabletSCDcad14805-64d8-4257-b5f1-d56e0063f0e27
1099292desipramine hydrochloride 100 MG Oral TabletSCDcad14805-64d8-4257-b5f1-d56e0063f0e27
1099296desipramine hydrochloride 150 MG Oral TabletSCDcad14805-64d8-4257-b5f1-d56e0063f0e27
1099300desipramine hydrochloride 25 MG Oral TabletSCDcad14805-64d8-4257-b5f1-d56e0063f0e27
1099304desipramine hydrochloride 50 MG Oral TabletSCDcad14805-64d8-4257-b5f1-d56e0063f0e27
1099316desipramine hydrochloride 75 MG Oral TabletSCDcad14805-64d8-4257-b5f1-d56e0063f0e27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-320-306233203203030 TABLET, FILM COATED in 1 BOTTLE (62332-320-30) 2021-07-080000-00-00NoNoCurrent
62332-320-3162332032031100 TABLET, FILM COATED in 1 BOTTLE (62332-320-31) 2021-07-080000-00-00NoNoCurrent
62332-320-506233203205050 TABLET, FILM COATED in 1 BOTTLE (62332-320-50) 2021-07-080000-00-00NoNoCurrent
62332-320-91623320320911000 TABLET, FILM COATED in 1 BOTTLE (62332-320-91) 2021-07-080000-00-00NoNoCurrent