Home NDC 59746-710 Clomipramine Hydrochloride
Product NDC 59746-710
11-digit product format 597460710
Labeler code 59746
Product ID 59746-710_e9402f3a-49dc-49d9-8ddf-cd940bfb28a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clomipramine HCl
Dosage form CAPSULE
Route ORAL
Labeler JUBILANT CADISTA PHARMACEUTICALS INC.
Application ANDA212218
Marketing category ANDA
Marketing start 2019-12-01
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 2020-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59746-710-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59746-710-90 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59746-710-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59746-710-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59746-710-90 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59746-710-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59746-710-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59746-710-90 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59746-710-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59746-710-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59746-710-90 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59746-710-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59746-710-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59746-710-90 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59746-710-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59746-710-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59746-710-90 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59746-710-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59746-710-90 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59746-710-30 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59746-710-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59746-710-90 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59746-710-30 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59746-710-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59746-710-90 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59746-710-30 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59746-710-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A212218-001 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 A212218-002 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 A212218-003 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21
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 · 123 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 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 59746-710-01 2025-12-31 Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only 59746-710-30 2025-12-31 Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only 59746-710-90 2025-12-31 Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only 59746-710-01 2025-01-30 Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only 59746-710-30 2025-01-30 Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only 59746-710-90 2025-01-30 Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59746-710 CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HCL) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 Legacy NDC 20191201_84f5249b-c3e4-4e4a-abb6-d5b3ff6cbf4b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59746-710-01 59746071001 100 CAPSULE in 1 BOTTLE (59746-710-01) 100 capsule 2019-12-01 0000-00-00 No No Current 59746-710-30 59746071030 30 CAPSULE in 1 BOTTLE (59746-710-30) 30 capsule 2019-12-01 0000-00-00 No No Current 59746-710-90 59746071090 90 CAPSULE in 1 BOTTLE (59746-710-90) 90 capsule 2019-12-01 0000-00-00 No No Current