Home NDC 59651-382 Clomipramine Hydrochloride
Product NDC 59651-382
11-digit product format 596510382
Labeler code 59651
Product ID 59651-382_7d11010e-cf0f-4315-aced-7927a486a1ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clomipramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA216440
Marketing category ANDA
Marketing start 2023-03-20
Substance CLOMIPRAMINE 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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 59651-382 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 59651-382 59651-382-29 UNFINISHED Active or certified unfinished drug listing 2026-08-17
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 · 28 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 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 59651-382-29 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 59651-382-29 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 59651-382-29 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 59651-382-29 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 59651-382-29 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 59651-382-29 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 59651-382-29 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 59651-382-29 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 59651-382-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 59651-382-29 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 59651-382-29 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 59651-382-29 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 59651-382-29 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 59651-382-29 50b4072663b7…eae3003ed65e…
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 A216440-001 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 A216440-002 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 A216440-003 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20
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 2 · 72 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 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216440-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2023-03-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216440-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2023-03-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216440-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2023-03-20 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clomipramine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOMIPRAMINE 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 2LXW0L6GWJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857297 Internal RxNorm lookup 857301 Internal RxNorm lookup 857305 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 59651-382-01 Clomipramine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 1 59651-382-30 Clomipramine Hydrochloride 30 in 1 BOTTLE CAPSULE 30 1 59651-382-90 Clomipramine Hydrochloride 90 in 1 BOTTLE CAPSULE 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-382 CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED] 1 Current NDC, 3 package rows 20230408_7d11010e-cf0f-4315-aced-7927a486a1ef.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 Units Marketing start Sample Exclude flag Status 59651-382-01 59651038201 100 CAPSULE in 1 BOTTLE (59651-382-01) 100 capsule 2023-03-20 No No Current 59651-382-29 59651038229 1500 CAPSULE in 1 BAG (59651-382-29) 1500 capsule 20-MAR-23 Current 59651-382-30 59651038230 30 CAPSULE in 1 BOTTLE (59651-382-30) 30 capsule 2023-03-20 No No Current 59651-382-90 59651038290 90 CAPSULE in 1 BOTTLE (59651-382-90) 90 capsule 2023-03-20 No No Current