FDA.reportPublic FDA data

Clomipramine Hydrochloride

Product NDC
69025-005
11-digit product format
690250005
Labeler code
69025
Product ID
69025-005_a9f11866-54a1-308b-e053-2995a90a6e15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aizant Drug Research Solutions PVT LTD
Application
ANDA213221
Marketing category
ANDA
Marketing start
2020-05-17
Marketing end
0000-00-00
Substance
CLOMIPRAMINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213221-001CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22
A213221-002CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22
A213221-003CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22

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 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-2284e616aacf4f…
2026-09-14 22:38:342026-08A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-2284e616aacf4f…
2026-09-14 22:38:342026-08A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-2284e616aacf4f…
2026-08-18 06:07:402026-07A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-01-26 05:58 UTC2023-01A213221-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A213221-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213221-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213221-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213221-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213221-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A213221-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A213221-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213221-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A213221-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A213221-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213221-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213221-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213221-003AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69025-005-306902500053030 CAPSULE in 1 BOTTLE (69025-005-30) 30 capsule2020-05-170000-00-00NoNoCurrent
69025-005-906902500059090 CAPSULE in 1 BOTTLE (69025-005-90) 90 capsule2020-05-170000-00-00NoNoCurrent