clomiPRAMINE Hydrochloride

Product NDC
10135-700
11-digit product format
101350700
Labeler code
10135
Product ID
10135-700_cd41b705-ed9a-2910-e053-2995a90a6ed5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOMIPRAMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA210653
Marketing category
ANDA
Marketing start
2020-05-01
Marketing end
0000-00-00
Substance
CLOMIPRAMINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-700-012023-01-30C16284748780-1f386c64a-221b-0266-e053-dadaa90a7c1aclomiPRAMINE Hydrochloride Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-700-01clomiPRAMINE Hydrochloride100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-700-01EA - Each10135-700252a1508-f4ac-4b4e-b62d-2e104634e69212020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-700CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MARLEX PHARMACEUTICALS INC]3Legacy NDC, 1 package rows20211003_7a2d0cf1-dabe-430d-90f7-74973cba48e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSN7a2d0cf1-dabe-430d-90f7-74973cba48e33
857301clomiPRAMINE HCl 50 MG Oral CapsulePSN7a2d0cf1-dabe-430d-90f7-74973cba48e33
857305clomiPRAMINE HCl 75 MG Oral CapsulePSN7a2d0cf1-dabe-430d-90f7-74973cba48e33
857297clomipramine hydrochloride 25 MG Oral CapsuleSCD7a2d0cf1-dabe-430d-90f7-74973cba48e33
857301clomipramine hydrochloride 50 MG Oral CapsuleSCD7a2d0cf1-dabe-430d-90f7-74973cba48e33
857305clomipramine hydrochloride 75 MG Oral CapsuleSCD7a2d0cf1-dabe-430d-90f7-74973cba48e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-700-0110135070001100 CAPSULE in 1 BOTTLE (10135-700-01) 100 capsule2020-05-010000-00-00NoNoCurrent