Desipramine Hydrochloride

Product NDC
71335-0208
Requested package NDC
71335-0208-2
11-digit product format
713350208
Labeler code
71335
Product ID
71335-0208_731e919e-9c0b-4693-b462-b1712a413fe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desipramine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208105
Marketing category
ANDA
Marketing start
2016-03-21
Marketing end
0000-00-00
Substance
DESIPRAMINE HYDROCHLORIDE
Active strength
100 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-020871335-0208-2DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A208105-001DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-03-17
A208105-002DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-03-17
A208105-003DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-03-17
A208105-004DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-03-17
A208105-005DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-03-17
A208105-006DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-03-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A208105-001AB
A208105-002AB
A208105-003AB
A208105-004AB
A208105-005AB
A208105-006AB

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 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208105-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A208105-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A208105-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A208105-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A208105-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A208105-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-03-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208105-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208105-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208105-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208105-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208105-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208105-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208105-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208105-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208105-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208105-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208105-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208105-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208105-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208105-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208105-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208105-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208105-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208105-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208105-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208105-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208105-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208105-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208105-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208105-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208105-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208105-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208105-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208105-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208105-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208105-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208105-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208105-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208105-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208105-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-03-1703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208105-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208105-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208105-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208105-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208105-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208105-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208105-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208105-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208105-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208105-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208105-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208105-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208105-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208105-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208105-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208105-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208105-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208105-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208105-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208105-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208105-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208105-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208105-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208105-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208105-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208105-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208105-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208105-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208105-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208105-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208105-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208105-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208105-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208105-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208105-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208105-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208105-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208105-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208105-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208105-004AB103ed91905a0d…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desipramine HydrochlorideDESIPRAMINEAmneal Pharmaceuticals NY LLCa3b4b25d-0ddb-4531-badb-f1ba3168ac072026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208105
application number: ANDA208105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0208-271335020802100 TABLET, FILM COATED in 1 BOTTLE (71335-0208-2) 2022-02-090000-00-00NoNoCurrent