Clomipramine Hydrochloride

Product NDC
16714-849
11-digit product format
167140849
Labeler code
16714
Product ID
16714-849_57601a94-de02-4050-bbcf-fd7e6ac25825
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Northstar Rx LLC.
Application
ANDA208961
Marketing category
ANDA
Marketing start
2018-08-27
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, 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
16714-849-01Clomipramine Hydrochloride30 in 1 BOTTLECAPSULE303
16714-849-02Clomipramine Hydrochloride90 in 1 BOTTLECAPSULE903
16714-849-03Clomipramine Hydrochloride100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-849-01EA - Each16714-8497e445018-4e38-4c19-b549-b295c739e8aa12019-02-13
16714-849-02EA - Each16714-849e75fb5c8-3e65-4e52-8629-ba0379631c8212019-02-13
16714-849-03EA - Each16714-849efb3e63f-4a8a-40ec-8757-cc183959c28912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-849CLOMIPRAMINE HYDROCHLORIDE CAPSULE [NORTHSTAR RX LLC.]3Current NDC, Legacy NDC, 3 package rows20221130_b1809cb2-c6a8-451a-b692-506456c4efc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSNb1809cb2-c6a8-451a-b692-506456c4efc33
857301clomiPRAMINE HCl 50 MG Oral CapsulePSNb1809cb2-c6a8-451a-b692-506456c4efc33
857305clomiPRAMINE HCl 75 MG Oral CapsulePSNb1809cb2-c6a8-451a-b692-506456c4efc33
857297clomipramine hydrochloride 25 MG Oral CapsuleSCDb1809cb2-c6a8-451a-b692-506456c4efc33
857301clomipramine hydrochloride 50 MG Oral CapsuleSCDb1809cb2-c6a8-451a-b692-506456c4efc33
857305clomipramine hydrochloride 75 MG Oral CapsuleSCDb1809cb2-c6a8-451a-b692-506456c4efc33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-849-011671408490130 CAPSULE in 1 BOTTLE (16714-849-01) 30 capsule2018-08-270000-00-00NoNoCurrent
16714-849-021671408490290 CAPSULE in 1 BOTTLE (16714-849-02) 90 capsule2018-08-270000-00-00NoNoCurrent
16714-849-0316714084903100 CAPSULE in 1 BOTTLE (16714-849-03) 100 capsule2018-08-270000-00-00NoNoCurrent