Clomipramine Hydrochloride Capsules, USP

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-26
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:48:30

Label at a glance#

ProductClomipramine Hydrochloride
Active ingredientCLOMIPRAMINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1012-1

Clomipramine Hydrochloride Capsules USP, 25 mg

Rx only

100 Capsules

Clomipramine Hydrochloride Capsules, USP
Clomipramine Hydrochloride Capsules, USP

NDC 70771-1013-1

Clomipramine Hydrochloride Capsules USP, 50 mg

Rx only

100 Capsules

Clomipramine Hydrochloride Capsules, USP
Clomipramine Hydrochloride Capsules, USP

NDC 70771-1014-1

Clomipramine Hydrochloride Capsules USP, 75 mg

Rx only

100 Capsules

Clomipramine Hydrochloride Capsules, USP
Clomipramine Hydrochloride Capsules, USP

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 63 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A208961-001CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-27
A208961-002CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-27
A208961-003CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A208961-001AB
A208961-002AB
A208961-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-2784e616aacf4f…
2026-08-18 06:07:402026-07A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-27301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208961-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208961-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208961-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A208961-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208961-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208961-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208961-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208961-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208961-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208961-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208961-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208961-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208961-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208961-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208961-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208961-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208961-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208961-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208961-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208961-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208961-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208961-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208961-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208961-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208961-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208961-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208961-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208961-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208961-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208961-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208961-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208961-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208961-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208961-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208961-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208961-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208961-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208961-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208961-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208961-001AB1301d65b070ca…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
82f8cc6c-a48e-4e1c-be01-e2c5f00c15afdb72b569-7b2c-4787-bade-7eef7299a7682024-11-26Exact identifier
spl id: 82f8cc6c-a48e-4e1c-be01-e2c5f00c15af
spl set id: db72b569-7b2c-4787-bade-7eef7299a768

Reported adverse events (FAERS/openFDA)#

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