Home NDC 70710-1065-9 Clomipramine Hydrochloride
Product NDC 70710-1065
Requested package NDC 70710-1065-9
11-digit product format 707101065
Labeler code 70710
Product ID 70710-1065_a988ebbb-6e0c-43ff-83a8-0cc0dc4259ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clomipramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA208961
Marketing category ANDA
Marketing start 2018-05-03
Marketing end 0000-00-00
Substance CLOMIPRAMINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70710-1065 70710-1065-9 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70710-1065 70710-1065-9 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208961-001 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 A208961-002 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 A208961-003 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70710-1065-9 70710106509 90 CAPSULE in 1 BOTTLE (70710-1065-9) 90 capsule 2018-05-03 0000-00-00 No No Current