DESIPRAMINE HYDROCHLORIDE

Product NDC
46708-317
11-digit product format
467080317
Labeler code
46708
Product ID
46708-317_878a2586-20af-4f35-8908-82474cc732a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESIPRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA209785
Marketing category
ANDA
Marketing start
2021-07-08
Substance
DESIPRAMINE HYDROCHLORIDE
Active strength
50 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
A209785-001DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2021-07-07
A209785-002DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2021-07-07
A209785-003DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2021-07-07
A209785-004DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2021-07-07
A209785-005DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2021-07-07
A209785-006DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2021-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209785-001AB
A209785-002AB
A209785-003AB
A209785-004AB
A209785-005AB
A209785-006AB

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 6 · 204 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209785-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2021-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A209785-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2021-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A209785-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2021-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A209785-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2021-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A209785-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2021-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A209785-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2021-07-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209785-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209785-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209785-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209785-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209785-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209785-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2021-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209785-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209785-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209785-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209785-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209785-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209785-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2021-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209785-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2021-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209785-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2021-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209785-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2021-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209785-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2021-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209785-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2021-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209785-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2021-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209785-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2021-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209785-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2021-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209785-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2021-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209785-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2021-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209785-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2021-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209785-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2021-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209785-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2021-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209785-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2021-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209785-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2021-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209785-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2021-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209785-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2021-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209785-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2021-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209785-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2021-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209785-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2021-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209785-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2021-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209785-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2021-07-0703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209785-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209785-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209785-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209785-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209785-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209785-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209785-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209785-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209785-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209785-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209785-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209785-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209785-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209785-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209785-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209785-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209785-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209785-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209785-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209785-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209785-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209785-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209785-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209785-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209785-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209785-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209785-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209785-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209785-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209785-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209785-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209785-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209785-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209785-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209785-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209785-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209785-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209785-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209785-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209785-004AB103ed91905a0d…

Additional Listing Data#

Finished product
Yes
Brand name base
DESIPRAMINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESIPRAMINE HYDROCHLORIDE50 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
8b6d2289-aac9-4007-a73d-c168fd2e1d9eAvailable on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-317-30DESIPRAMINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302
46708-317-31DESIPRAMINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1002
46708-317-91DESIPRAMINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-317DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 3 package rows20230202_8b6d2289-aac9-4007-a73d-c168fd2e1d9e.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 HYDROCHLORIDEAlembic Pharmaceuticals Inc.cad14805-64d8-4257-b5f1-d56e0063f0e22025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209785
application number: ANDA209785
DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Limited8b6d2289-aac9-4007-a73d-c168fd2e1d9e2023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209785
application number: ANDA209785
ndc (product): 46708-317

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099288desipramine HCl 10 MG Oral TabletPSN8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099292desipramine HCl 100 MG Oral TabletPSN8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099296desipramine HCl 150 MG Oral TabletPSN8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099300desipramine HCl 25 MG Oral TabletPSN8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099304desipramine HCl 50 MG Oral TabletPSN8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099316desipramine HCl 75 MG Oral TabletPSN8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099288desipramine hydrochloride 10 MG Oral TabletSCD8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099292desipramine hydrochloride 100 MG Oral TabletSCD8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099296desipramine hydrochloride 150 MG Oral TabletSCD8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099300desipramine hydrochloride 25 MG Oral TabletSCD8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099304desipramine hydrochloride 50 MG Oral TabletSCD8b6d2289-aac9-4007-a73d-c168fd2e1d9e2
1099316desipramine hydrochloride 75 MG Oral TabletSCD8b6d2289-aac9-4007-a73d-c168fd2e1d9e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-317-304670803173030 TABLET, FILM COATED in 1 BOTTLE (46708-317-30) 2021-07-080000-00-00NoNoCurrent
46708-317-3146708031731100 TABLET, FILM COATED in 1 BOTTLE (46708-317-31) 2021-07-080000-00-00NoNoCurrent
46708-317-91467080317911000 TABLET, FILM COATED in 1 BOTTLE (46708-317-91) 2021-07-080000-00-00NoNoCurrent