FDA.reportPublic FDA data

Clomipramine Hydrochloride

Product NDC
71205-912
11-digit product format
712050912
Labeler code
71205
Product ID
71205-912_be10b430-6ed9-4241-b6d9-818846e80839
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211364
Marketing category
ANDA
Marketing start
2020-03-10
Substance
CLOMIPRAMINE HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 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
71205-912-00Clomipramine Hydrochloride100 in 1 BOTTLECAPSULE1002
71205-912-11Clomipramine Hydrochloride1000 in 1 BOTTLECAPSULE10002
71205-912-30Clomipramine Hydrochloride30 in 1 BOTTLECAPSULE302
71205-912-55Clomipramine Hydrochloride500 in 1 BOTTLECAPSULE5002
71205-912-60Clomipramine Hydrochloride60 in 1 BOTTLECAPSULE602
71205-912-90Clomipramine Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-912-00EA - Each71205-912daa9e262-d85d-46af-8cfa-7aa15eccb06312021-08-05
71205-912-11EA - Each71205-9124a69e85a-5498-4250-9ca2-c0dc9c0daf0a12021-08-05
71205-912-30EA - Each71205-9120e7edc4b-9dfd-45bc-8ea2-4541dc4d895812021-08-05
71205-912-60EA - Each71205-9121f779a24-8bfb-47bd-8a94-009e7a38f51a12021-08-05
71205-912-90EA - Each71205-9129d456730-b818-43d5-aa89-3285ef30ebd512021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-912CLOMIPRAMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20220415_ff9ed80e-d692-494f-9741-a9af30fa5000.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSNff9ed80e-d692-494f-9741-a9af30fa50002
857301clomiPRAMINE HCl 50 MG Oral CapsulePSNff9ed80e-d692-494f-9741-a9af30fa50002
857305clomiPRAMINE HCl 75 MG Oral CapsulePSNff9ed80e-d692-494f-9741-a9af30fa50002
857297clomipramine hydrochloride 25 MG Oral CapsuleSCDff9ed80e-d692-494f-9741-a9af30fa50002
857301clomipramine hydrochloride 50 MG Oral CapsuleSCDff9ed80e-d692-494f-9741-a9af30fa50002
857305clomipramine hydrochloride 75 MG Oral CapsuleSCDff9ed80e-d692-494f-9741-a9af30fa50002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-912-0071205091200100 CAPSULE in 1 BOTTLE (71205-912-00) 100 capsule2021-07-160000-00-00NoNoCurrent
71205-912-11712050912111000 CAPSULE in 1 BOTTLE (71205-912-11) 1000 capsule2021-07-160000-00-00NoNoCurrent
71205-912-307120509123030 CAPSULE in 1 BOTTLE (71205-912-30) 30 capsule2021-07-160000-00-00NoNoCurrent
71205-912-5571205091255500 CAPSULE in 1 BOTTLE (71205-912-55) 500 capsule2021-07-160000-00-00NoNoCurrent
71205-912-607120509126060 CAPSULE in 1 BOTTLE (71205-912-60) 60 capsule2021-07-160000-00-00NoNoCurrent
71205-912-907120509129090 CAPSULE in 1 BOTTLE (71205-912-90) 90 capsule2021-07-160000-00-00NoNoCurrent