CLOMIPRAMINE HYDROCHLORIDE

Product NDC
0904-7038
11-digit product format
009047038
Labeler code
0904
Product ID
0904-7038_b7641ab7-974c-4814-97ba-44cf2ca7e10f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA074694
Marketing category
ANDA
Marketing start
1996-12-31
Substance
CLOMIPRAMINE 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
CLOMIPRAMINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOMIPRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2LXW0L6GWJ
Rxcui857297, 857301

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
0904-7038-07CLOMIPRAMINE HYDROCHLORIDE1 in 1 BLISTER PACKCAPSULE15
0904-7038-07CLOMIPRAMINE HYDROCHLORIDE30 in 1 CARTONCAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7038-07EA - Each0904-703881b855da-c9c5-4df2-bf81-59b0dc5eda1312020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7038CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20250330_eff91018-5a5e-4426-96ae-71ecd82273b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSNeff91018-5a5e-4426-96ae-71ecd82273b75
857301clomiPRAMINE HCl 50 MG Oral CapsulePSNeff91018-5a5e-4426-96ae-71ecd82273b75
857297clomipramine hydrochloride 25 MG Oral CapsuleSCDeff91018-5a5e-4426-96ae-71ecd82273b75
857301clomipramine hydrochloride 50 MG Oral CapsuleSCDeff91018-5a5e-4426-96ae-71ecd82273b75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7038-070090470380730 BLISTER PACK in 1 CARTON (0904-7038-07) / 1 CAPSULE in 1 BLISTER PACK30 blister pack1996-12-310000-00-00NoNoCurrent