Clomipramine HCl

Product NDC
69238-1109
11-digit product format
692381109
Labeler code
69238
Product ID
69238-1109_c4aef914-a0aa-487b-a9d4-b4357ec400d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208632
Marketing category
ANDA
Marketing start
2018-10-31
Marketing end
0000-00-00
Substance
CLOMIPRAMINE HYDROCHLORIDE
Active strength
50 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
69238-1109-3EA - Each69238-11097ceb29f9-c057-4002-87c1-461c7838169b12019-02-13
69238-1109-9EA - Each69238-1109b0b27562-23e2-49a6-8ff9-7b55ffaf86ce12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1109CLOMIPRAMINE HCL CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]11Legacy NDC20241218_b1739aa5-69d8-4a69-be58-6d789ea2a516.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1109-36923811090330 CAPSULE in 1 BOTTLE (69238-1109-3) 30 capsule2018-10-310000-00-00NoNoCurrent
69238-1109-96923811090990 CAPSULE in 1 BOTTLE (69238-1109-9) 90 capsule2018-10-310000-00-00NoNoCurrent