Trimipramine Maleate

Product NDC
42806-803
11-digit product format
428060803
Labeler code
42806
Product ID
42806-803_c9cbd807-7a84-4285-928e-63bc11db6c9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trimipramine Maleate
Dosage form
CAPSULE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA077361
Marketing category
ANDA
Marketing start
2021-03-16
Marketing end
0000-00-00
Substance
TRIMIPRAMINE MALEATE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42806-803DDiscontinued by firm2026-08-03
excluded packagepackage42806-80342806-803-30DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct42806-803DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42806-80342806-803-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct42806-803DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42806-80342806-803-30DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct42806-803DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42806-80342806-803-30DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct42806-803DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42806-80342806-803-30DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct42806-803DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42806-80342806-803-30DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct42806-803DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42806-80342806-803-30DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct42806-803DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42806-80342806-803-30DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct42806-803DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42806-80342806-803-30DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct42806-803DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42806-80342806-803-30DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct42806-803DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42806-80342806-803-30DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct42806-803DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42806-80342806-803-30DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct42806-803DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42806-80342806-803-30DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077361-001TRIMIPRAMINE MALEATETRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-02
A077361-002TRIMIPRAMINE MALEATETRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-02
A077361-003TRIMIPRAMINE MALEATETRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077361-001AB
A077361-002AB
A077361-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077361-002TRIMIPRAMINE MALEATEEQ 50MG BASECAPSULE / ORALAB2006-08-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077361-003TRIMIPRAMINE MALEATEEQ 100MG BASECAPSULE / ORALAB2006-08-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077361-001TRIMIPRAMINE MALEATEEQ 25MG BASECAPSULE / ORALAB2006-08-028072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077361-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077361-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077361-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077361-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077361-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077361-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077361-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077361-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077361-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077361-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077361-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077361-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077361-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077361-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077361-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077361-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077361-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077361-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077361-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077361-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077361-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077361-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077361-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077361-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077361-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077361-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077361-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077361-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077361-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077361-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077361-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077361-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077361-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077361-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077361-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077361-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077361-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077361-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077361-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077361-001AB18072bd15b7f6…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trimipramine MaleateTRIMIPRAMINE MALEATEBryant Ranch Prepack326ef804-8d3a-425e-8513-8c9811856aa02023-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077361
application number: ANDA077361
Trimipramine MaleateTRIMIPRAMINE MALEATEBryant Ranch Prepacke4ff3409-f1bf-4851-a848-be1fcc4b12172023-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077361
application number: ANDA077361
Trimipramine MaleateTRIMIPRAMINE MALEATEBryant Ranch Prepack479c7dc5-61e1-4bf2-b0bd-5d80865192af2023-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077361
application number: ANDA077361
Trimipramine MaleateTRIMIPRAMINE MALEATEElite Laboratories, Inc.59c25dd3-7ab0-4e7f-b839-367db9eeccd22019-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077361
application number: ANDA077361

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-803-30EA - Each42806-80396ab26bb-e560-423e-b39e-e925ab9688e812021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-803-304280608033030 CAPSULE in 1 BOTTLE (42806-803-30) 30 capsule2021-03-160000-00-00NoNoCurrent