Home NDC 72189-391-30 Desipramine HCL
Product NDC 72189-391
Requested package NDC 72189-391-30
11-digit product format 721890391
Labeler code 72189
Product ID 72189-391_2c4cdf7a-45d8-784b-e063-6294a90a82b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desipramine HCL
Dosage form TABLET
Route ORAL
Labeler Direct_Rx
Application ANDA204963
Marketing category ANDA
Marketing start 2022-11-16
Substance DESIPRAMINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-391 72189-391-30 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-391 72189-391-30 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A204963-001 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-12-26 A204963-002 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-12-26 A204963-003 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-12-26 A204963-004 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2017-12-26 A204963-005 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-26 A204963-006 DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-12-26
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 · 246 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 2026-02-19 14:30 UTC 2026-02 A204963-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204963-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204963-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204963-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2017-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204963-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204963-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204963-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204963-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204963-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204963-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2017-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204963-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204963-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204963-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204963-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204963-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204963-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2017-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204963-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204963-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204963-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204963-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204963-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204963-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2017-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204963-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204963-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204963-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204963-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204963-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204963-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2017-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204963-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204963-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204963-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204963-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204963-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204963-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2017-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204963-005 DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204963-006 DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204963-001 DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204963-002 DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204963-003 DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204963-004 DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2017-12-26 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Desipramine HCL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESIPRAMINE HYDROCHLORIDE 10 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1099288 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 72189-391-30 Desipramine HCL 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-391 DESIPRAMINE HCL TABLET [DIRECT_RX] 2 Current NDC, Legacy NDC, 1 package rows 20250123_ed9d2290-9ad9-ecff-e053-2a95a90a5fd6.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72189-391-30 72189039130 30 TABLET in 1 BOTTLE (72189-391-30) 30 tablet 2022-11-16 0000-00-00 No No Current