CLOMIPRAMINE HYDROCHLORIDE

Product NDC
46708-409
11-digit product format
467080409
Labeler code
46708
Product ID
46708-409_d6ecf659-e7e9-404b-98c0-999c30d485eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOMIPRAMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA211822
Marketing category
ANDA
Marketing start
2021-08-05
Substance
CLOMIPRAMINE HYDROCHLORIDE
Active strength
75 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
CLOMIPRAMINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOMIPRAMINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2LXW0L6GWJ
Rxcui857297, 857301, 857305

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06ad84c7-ef7f-2b11-27cb-22ae93f433b6Product name920240422

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-409-30CLOMIPRAMINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE304
46708-409-31CLOMIPRAMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE1004
46708-409-90CLOMIPRAMINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-409CLOMIPRAMINE HYDROCHLORIDE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 3 package rows20230129_1b62b3c0-baf7-4c6b-815f-8707ce1f38c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSN1b62b3c0-baf7-4c6b-815f-8707ce1f38c44
857301clomiPRAMINE HCl 50 MG Oral CapsulePSN1b62b3c0-baf7-4c6b-815f-8707ce1f38c44
857305clomiPRAMINE HCl 75 MG Oral CapsulePSN1b62b3c0-baf7-4c6b-815f-8707ce1f38c44
857297clomipramine hydrochloride 25 MG Oral CapsuleSCD1b62b3c0-baf7-4c6b-815f-8707ce1f38c44
857301clomipramine hydrochloride 50 MG Oral CapsuleSCD1b62b3c0-baf7-4c6b-815f-8707ce1f38c44
857305clomipramine hydrochloride 75 MG Oral CapsuleSCD1b62b3c0-baf7-4c6b-815f-8707ce1f38c44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-409-304670804093030 CAPSULE in 1 BOTTLE (46708-409-30) 30 capsule2021-08-050000-00-00NoNoCurrent
46708-409-3146708040931100 CAPSULE in 1 BOTTLE (46708-409-31) 100 capsule2021-08-050000-00-00NoNoCurrent
46708-409-904670804099090 CAPSULE in 1 BOTTLE (46708-409-90) 90 capsule2021-08-050000-00-00NoNoCurrent