Home NDC 69238-1055 Desipramine Hydrochloride
Product NDC 69238-1055
11-digit product format 692381055
Labeler code 69238
Product ID 69238-1055_1b88bc17-fcbe-47ff-af6d-8f28c1a3ca17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desipramine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA208105
Marketing category ANDA
Marketing start 2016-03-21
Substance DESIPRAMINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208105-001 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-03-17 A208105-002 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-03-17 A208105-003 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-03-17 A208105-004 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2016-03-17 A208105-005 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-03-17 A208105-006 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2016-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A208105-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208105-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208105-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208105-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2016-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208105-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208105-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2016-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208105-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208105-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208105-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208105-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2016-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208105-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208105-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2016-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208105-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208105-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208105-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208105-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2016-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208105-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208105-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2016-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208105-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208105-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208105-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208105-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2016-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208105-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208105-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2016-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208105-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208105-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208105-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208105-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2016-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208105-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208105-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2016-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208105-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208105-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208105-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208105-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2016-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208105-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208105-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2016-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208105-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208105-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208105-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208105-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2016-03-17 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 252 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Desipramine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESIPRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1Y58DO4MY1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1099288 Internal RxNorm lookup 1099292 Internal RxNorm lookup 1099296 Internal RxNorm lookup 1099300 Internal RxNorm lookup 1099304 Internal RxNorm lookup 1099316 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69238-1055-1 Desipramine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 13 69238-1055-3 Desipramine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1055 DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] 11 Current NDC, Legacy NDC, 2 package rows 20241218_a3b4b25d-0ddb-4531-badb-f1ba3168ac07.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69238-1055-1 69238105501 100 TABLET, FILM COATED in 1 BOTTLE (69238-1055-1) 2016-03-21 0000-00-00 No No Current 69238-1055-3 69238105503 30 TABLET, FILM COATED in 1 BOTTLE (69238-1055-3) 2016-03-21 0000-00-00 No No Current