Home NDC 0955-1030 Desipramine Hydrochloride
Product NDC 0955-1030
11-digit product format 009551030
Labeler code 0955
Product ID 0955-1030_daa6bf83-2037-4fa2-b2ae-114873b8337e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name desipramine hydrochloride
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler Winthrop U.S.
Application NDA014399
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-04-01
Marketing end 2019-08-28
Substance DESIPRAMINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0955-1030-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0955-1030-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0955-1030-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0955-1030-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0955-1030-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0955-1030-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0955-1030-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0955-1030-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0955-1030-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0955-1030-10 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0955-1030-10 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0955-1030-10 557ba5c1ecfa…9c80585c8c6e…
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 N014399-001 NORPRAMIN DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL RLD, Approved before 1982 N014399-003 NORPRAMIN DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL RLD, Approved before 1982 N014399-004 NORPRAMIN DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL RLD, Approved before 1982 N014399-005 NORPRAMIN DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL RLD, Approved before 1982 N014399-006 NORPRAMIN DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL RLD, Approved before 1982 N014399-007 NORPRAMIN DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL RLD 1982-02-11
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 N014399-001 NORPRAMIN 25MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N014399-003 NORPRAMIN 50MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N014399-004 NORPRAMIN 75MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N014399-005 NORPRAMIN 100MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N014399-006 NORPRAMIN 150MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N014399-007 NORPRAMIN 10MG TABLET / ORAL RLD 1982-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N014399-001 NORPRAMIN 25MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N014399-003 NORPRAMIN 50MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N014399-004 NORPRAMIN 75MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N014399-005 NORPRAMIN 100MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N014399-006 NORPRAMIN 150MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N014399-007 NORPRAMIN 10MG TABLET / ORAL RLD 1982-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N014399-001 NORPRAMIN 25MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N014399-003 NORPRAMIN 50MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N014399-004 NORPRAMIN 75MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N014399-005 NORPRAMIN 100MG TABLET / ORAL AB RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N014399-006 NORPRAMIN 150MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N014399-007 NORPRAMIN 10MG TABLET / ORAL AB RLD 1982-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N014399-001 NORPRAMIN 25MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N014399-003 NORPRAMIN 50MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N014399-004 NORPRAMIN 75MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N014399-005 NORPRAMIN 100MG TABLET / ORAL AB RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N014399-006 NORPRAMIN 150MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N014399-007 NORPRAMIN 10MG TABLET / ORAL AB RLD 1982-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N014399-001 NORPRAMIN 25MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N014399-003 NORPRAMIN 50MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N014399-004 NORPRAMIN 75MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N014399-005 NORPRAMIN 100MG TABLET / ORAL AB RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N014399-006 NORPRAMIN 150MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N014399-007 NORPRAMIN 10MG TABLET / ORAL AB RLD 1982-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N014399-001 NORPRAMIN 25MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N014399-003 NORPRAMIN 50MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N014399-004 NORPRAMIN 75MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N014399-005 NORPRAMIN 100MG TABLET / ORAL AB RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N014399-006 NORPRAMIN 150MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N014399-007 NORPRAMIN 10MG TABLET / ORAL AB RLD 1982-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N014399-001 NORPRAMIN 25MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N014399-003 NORPRAMIN 50MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N014399-004 NORPRAMIN 75MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N014399-005 NORPRAMIN 100MG TABLET / ORAL AB RLD, RS, Approved before 1982 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Norpramin DESIPRAMINE HYDROCHLORIDE Validus Pharmaceuticals LLC 70b562ea-9f21-4e4a-b3ed-0590b2892f6a 2025-07-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 014399 application number: NDA014399