FDA.reportPublic FDA data

Trimipramine

Product NDC
51991-945
11-digit product format
519910945
Labeler code
51991
Product ID
51991-945_e1cadaf3-e932-4bfb-a8fa-57fb52f7dc67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trimipramine
Dosage form
CAPSULE
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA208127
Marketing category
ANDA
Marketing start
2017-04-05
Substance
TRIMIPRAMINE MALEATE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trimipramine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIMIPRAMINE MALEATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii269K6498LD
Rxcui313496, 313498, 313499

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1c70dfe2-7a86-036d-045f-091057d656a1Product name220160609

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51991-945-01Trimipramine100 in 1 BOTTLECAPSULE10017
51991-945-33Trimipramine30 in 1 BOTTLECAPSULE3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-945-01EA - Each51991-945261ceac6-966e-43fc-a62a-77f2e22aea5d12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-945TRIMIPRAMINE MALEATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]14Current NDC, Legacy NDC, 2 package rows20250209_4f31df66-7dc2-1f04-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313496trimipramine 100 MG Oral CapsulePSN4f31df66-7dc2-1f04-e054-00144ff88e8817
313498trimipramine 25 MG Oral CapsulePSN4f31df66-7dc2-1f04-e054-00144ff88e8817
313499trimipramine 50 MG Oral CapsulePSN4f31df66-7dc2-1f04-e054-00144ff88e8817
313496trimipramine 100 MG Oral CapsuleSCD4f31df66-7dc2-1f04-e054-00144ff88e8817
313498trimipramine 25 MG Oral CapsuleSCD4f31df66-7dc2-1f04-e054-00144ff88e8817
313499trimipramine 50 MG Oral CapsuleSCD4f31df66-7dc2-1f04-e054-00144ff88e8817
313496trimipramine 100 MG (as trimipramine maleate ) Oral CapsuleSY4f31df66-7dc2-1f04-e054-00144ff88e8817
313498trimipramine 25 MG (as trimipramine maleate ) Oral CapsuleSY4f31df66-7dc2-1f04-e054-00144ff88e8817
313499trimipramine 50 MG (as trimipramine maleate ) Oral CapsuleSY4f31df66-7dc2-1f04-e054-00144ff88e8817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-945-0151991094501100 CAPSULE in 1 BOTTLE (51991-945-01) 100 capsule2017-04-050000-00-00NoNoCurrent
51991-945-335199109453330 CAPSULE in 1 BOTTLE (51991-945-33) 30 capsule2019-06-110000-00-00NoNoCurrent