Desipramine Hydrochloride

Product NDC
21695-845
11-digit product format
216950845
Labeler code
21695
Product ID
21695-845_3433c754-cc2e-4e72-bd82-16ed4af3144d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desipramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074430
Marketing category
ANDA
Marketing start
1996-02-09
Marketing end
0000-00-00
Substance
DESIPRAMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct21695-845IInactivated by FDA2026-08-17
excluded packagepackage21695-84521695-845-60IInactivated by FDA2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-845-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-845-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-845-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-845-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-845-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-845-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-845-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-845-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-845-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-845-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-845-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-845-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-845-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-845-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-845-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-845-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-845-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-845-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-845-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-845-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-845-609bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-845-60110d247fa046…a55b01930146…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074430-001DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-09
A074430-002DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074430-001AB
A074430-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074430-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1996-02-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074430-002DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB1996-02-09bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074430-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074430-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074430-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074430-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074430-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074430-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074430-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074430-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074430-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074430-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074430-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074430-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074430-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074430-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074430-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074430-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074430-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074430-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074430-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074430-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074430-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074430-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074430-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074430-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074430-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074430-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074430-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074430-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074430-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074430-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074430-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074430-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074430-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074430-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074430-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074430-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074430-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074430-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074430-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074430-002AB1bb7c543d1eb4…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bda46dda-4ebd-3e63-0043-123c9d173af2Product name620220125

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-845-602019-09-24C16284748780-1934fe258-47c1-48b1-e053-8cdaa90a720aDESIPRAMINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-845-60Desipramine Hydrochloride60 in 1 BOTTLETABLET601

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-845DESIPRAMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110415_3433c754-cc2e-4e72-bd82-16ed4af3144d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desipramine HydrochlorideDESIPRAMINE HYDROCHLORIDEActavis Pharma, Inc.ba02a95d-d82e-4a13-90b4-a219abc0249a2025-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074430
application number: ANDA074430

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099288desipramine HCl 10 MG Oral TabletPSN3433c754-cc2e-4e72-bd82-16ed4af3144d1
1099288desipramine hydrochloride 10 MG Oral TabletSCD3433c754-cc2e-4e72-bd82-16ed4af3144d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-845-602169508456060 in 1 BOTTLEHistorical