DESIPRAMINE HYDROCHLORIDE

Product NDC
71335-1021
11-digit product format
713351021
Labeler code
71335
Product ID
71335-1021_9c8f89b0-5da1-42ca-a3dd-b81f6d4e7a73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desipramine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207433
Marketing category
ANDA
Marketing start
2016-11-01
Marketing end
0000-00-00
Substance
DESIPRAMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct71335-1021DDiscontinued by firm2026-08-10
excluded packagepackage71335-102171335-1021-1DDiscontinued by firm2026-08-10

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1021-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1021-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1021-1IInactivated by FDA1332a3947898…d4bfe170f9cd…

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207433-001DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2016-05-05
A207433-002DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2016-05-05
A207433-003DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2016-05-05
A207433-004DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE75MGTABLET / ORAL2016-05-05
A207433-005DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE100MGTABLET / ORAL2016-05-05
A207433-006DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE150MGTABLET / ORAL2016-05-05

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2016-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2016-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2016-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORAL2016-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORAL2016-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORAL2016-05-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-05-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-05-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-05-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-05-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-05-052680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 234 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207433-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-005AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-006AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207433-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207433-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207433-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207433-004AB15bbf6a4d5a75…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1021-12024-05-17C16284748780-11030e365-4117-111a-e063-dadaa90a10e2Desipramine Hydrochloride Tablets, USP
71335-1021-12024-01-30C16284748780-11030e365-4117-111a-e063-dadaa90a10e2Desipramine Hydrochloride Tablets, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1021DESIPRAMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3Legacy NDC20240518_9c8f89b0-5da1-42ca-a3dd-b81f6d4e7a73.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desipramine HydrochlorideDESIPRAMINE HYDROCHLORIDEChartwell RX, LLC6ab5e113-82ef-493d-a4e3-a2756608fa602025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207433
application number: ANDA207433
DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ee14dd2c-c54b-4cd1-a3a0-f7ad5a5a0ed02025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207433
application number: ANDA207433

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1021-17133510210130 TABLET in 1 BOTTLE (71335-1021-1) 30 tablet2018-12-130000-00-00NoNoCurrent