Home NDC 69238-1061 Desipramine Hydrochloride
Product NDC 69238-1061
11-digit product format 692381061
Labeler code 69238
Product ID 69238-1061_6ea5e8b8-b492-440b-9e38-4ef1c0b46ee2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desipramine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA208105
Marketing category ANDA
Marketing start 2016-03-21
Marketing end 2027-12-31
Substance DESIPRAMINE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 258 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 2026-09-14 22:38:34 2026-08 A208105-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208105-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208105-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208105-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2016-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208105-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208105-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2016-03-17 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Desipramine Hydrochloride Active Ingredients# Ingredient, Strength table Ingredient Strength DESIPRAMINE HYDROCHLORIDE 100 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69238-1061-1 Desipramine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 13 69238-1061-3 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 69238-1061 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
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 69238-1061-1 69238106101 100 TABLET, FILM COATED in 1 BOTTLE (69238-1061-1) 2016-03-21 2027-12-31 No No Current 69238-1061-3 69238106103 30 TABLET, FILM COATED in 1 BOTTLE (69238-1061-3) 2016-03-21 2027-12-31 No No Current