Home NDC 45963-343 Desipramine Hydrochloride
Product NDC 45963-343
11-digit product format 459630343
Labeler code 45963
Product ID 45963-343_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 ANDA071588
Marketing category ANDA
Marketing start 2006-06-04
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071588-001 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071588-001 AB
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 2 · 42 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 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071588-001 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-06-05 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Desipramine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESIPRAMINE HYDROCHLORIDE 50 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 45963-343-02 Desipramine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DESIPRAMINE HYDROCHLORIDE ACTIVE INGREDIENT 1Y58DO4MY1 DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12 DESIPRAMINE ACTIVE MOIETY TG537D343B DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12 POVIDONES INACTIVE INGREDIENT FZ989GH94E DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45963-343 DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 19 Current NDC, Legacy NDC, 1 package rows 20241114_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.
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 45963-343-02 45963034302 100 TABLET, FILM COATED in 1 BOTTLE (45963-343-02) 2006-06-04 0000-00-00 No No Current