Clomipramine Hydrochloride

Product NDC
52817-280
11-digit product format
528170280
Labeler code
52817
Product ID
52817-280_edabf702-d221-78ba-e053-2995a90ae7bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clomipramine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
TruPharma LLC
Application
ANDA210653
Marketing category
ANDA
Marketing start
2020-09-01
Marketing end
0000-00-00
Substance
CLOMIPRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-280-10EA - Each52817-28079ea8bbc-eebc-43bc-8ed1-3d2e6d67958012020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-280CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TRUPHARMA LLC]3Legacy NDC20221118_ac4f5271-83d1-797b-e053-2995a90a4f5e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-280-1052817028010100 CAPSULE in 1 BOTTLE (52817-280-10) 100 capsule2020-09-010000-00-00NoNoCurrent