Desipramine Hydrochloride

Product NDC
45963-341
11-digit product format
459630341
Labeler code
45963
Product ID
45963-341_cb512a98-31c9-4ae9-9cc9-1d102302cfea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA074430
Marketing category
ANDA
Marketing start
2006-05-09
Substance
DESIPRAMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Desipramine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESIPRAMINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1Y58DO4MY1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1099288Internal RxNorm lookup
1099292Internal RxNorm lookup
1099296Internal RxNorm lookup
1099300Internal RxNorm lookup
1099304Internal RxNorm lookup
1099316Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba02a95d-d82e-4a13-90b4-a219abc0249aAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45963-341-02Desipramine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-341-02EA - Each45963-341f4347ed8-c3b6-45dc-8489-5bab4f9be70e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESIPRAMINE HYDROCHLORIDEACTIVE INGREDIENT1Y58DO4MY1DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
DESIPRAMINEACTIVE MOIETYTG537D343BDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94EDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
DESIPRAMINE HYDROCHLORIDEACTIVE INGREDIENT1Y58DO4MY1DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
DESIPRAMINEACTIVE MOIETYTG537D343BDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
POVIDONESINACTIVE INGREDIENTFZ989GH94EDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-341DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]19Current NDC, Legacy NDC, 1 package rows20241114_ba02a95d-d82e-4a13-90b4-a219abc0249a.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
ndc (product): 45963-341

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099288desipramine HCl 10 MG Oral TabletPSNba02a95d-d82e-4a13-90b4-a219abc0249a21
1099292desipramine HCl 100 MG Oral TabletPSNba02a95d-d82e-4a13-90b4-a219abc0249a21
1099296desipramine HCl 150 MG Oral TabletPSNba02a95d-d82e-4a13-90b4-a219abc0249a21
1099300desipramine HCl 25 MG Oral TabletPSNba02a95d-d82e-4a13-90b4-a219abc0249a21
1099304desipramine HCl 50 MG Oral TabletPSNba02a95d-d82e-4a13-90b4-a219abc0249a21
1099316desipramine HCl 75 MG Oral TabletPSNba02a95d-d82e-4a13-90b4-a219abc0249a21
1099288desipramine hydrochloride 10 MG Oral TabletSCDba02a95d-d82e-4a13-90b4-a219abc0249a21
1099292desipramine hydrochloride 100 MG Oral TabletSCDba02a95d-d82e-4a13-90b4-a219abc0249a21
1099296desipramine hydrochloride 150 MG Oral TabletSCDba02a95d-d82e-4a13-90b4-a219abc0249a21
1099300desipramine hydrochloride 25 MG Oral TabletSCDba02a95d-d82e-4a13-90b4-a219abc0249a21
1099304desipramine hydrochloride 50 MG Oral TabletSCDba02a95d-d82e-4a13-90b4-a219abc0249a21
1099316desipramine hydrochloride 75 MG Oral TabletSCDba02a95d-d82e-4a13-90b4-a219abc0249a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45963-341-0245963034102100 TABLET, FILM COATED in 1 BOTTLE (45963-341-02) 2006-05-090000-00-00NoNoCurrent