Desipramine Hydrochloride

Product NDC
62135-594
11-digit product format
621350594
Labeler code
62135
Product ID
62135-594_45895d97-14b1-1beb-e063-6394a90a2930
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desipramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA207433
Marketing category
ANDA
Marketing start
2016-11-01
Substance
DESIPRAMINE HYDROCHLORIDE
Active strength
25 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 · 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 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2016-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2016-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2016-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORAL2016-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORAL2016-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORAL2016-05-05caaa826d4ba7…
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…

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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESIPRAMINE HYDROCHLORIDE25 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
6ab5e113-82ef-493d-a4e3-a2756608fa60Available 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
62135-594-12Desipramine Hydrochloride120 in 1 BOTTLETABLET1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-594-12EA - Each62135-59438becdb2-62cf-4750-9f37-b66ccc52811112023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-594DESIPRAMINE HYDROCHLORIDE TABLET [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241011_6ab5e113-82ef-493d-a4e3-a2756608fa60.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
ndc (product): 62135-594
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099288desipramine HCl 10 MG Oral TabletPSN6ab5e113-82ef-493d-a4e3-a2756608fa603
1099292desipramine HCl 100 MG Oral TabletPSN6ab5e113-82ef-493d-a4e3-a2756608fa603
1099296desipramine HCl 150 MG Oral TabletPSN6ab5e113-82ef-493d-a4e3-a2756608fa603
1099300desipramine HCl 25 MG Oral TabletPSN6ab5e113-82ef-493d-a4e3-a2756608fa603
1099304desipramine HCl 50 MG Oral TabletPSN6ab5e113-82ef-493d-a4e3-a2756608fa603
1099316desipramine HCl 75 MG Oral TabletPSN6ab5e113-82ef-493d-a4e3-a2756608fa603
1099288desipramine hydrochloride 10 MG Oral TabletSCD6ab5e113-82ef-493d-a4e3-a2756608fa603
1099292desipramine hydrochloride 100 MG Oral TabletSCD6ab5e113-82ef-493d-a4e3-a2756608fa603
1099296desipramine hydrochloride 150 MG Oral TabletSCD6ab5e113-82ef-493d-a4e3-a2756608fa603
1099300desipramine hydrochloride 25 MG Oral TabletSCD6ab5e113-82ef-493d-a4e3-a2756608fa603
1099304desipramine hydrochloride 50 MG Oral TabletSCD6ab5e113-82ef-493d-a4e3-a2756608fa603
1099316desipramine hydrochloride 75 MG Oral TabletSCD6ab5e113-82ef-493d-a4e3-a2756608fa603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-594-1262135059412120 TABLET in 1 BOTTLE (62135-594-12) 120 tablet2023-05-12NoNoCurrent