Clomipramine Hydrochloride

Product NDC
70771-1014
11-digit product format
707711014
Labeler code
70771
Product ID
70771-1014_4264806a-a5bc-46ee-b4f6-7a1ae0dfe331
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA208961
Marketing category
ANDA
Marketing start
2018-05-03
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70771-1014DDiscontinued by firm2026-08-17
excluded packagepackage70771-101470771-1014-1DDiscontinued by firm2026-08-17
excluded packagepackage70771-101470771-1014-7DDiscontinued by firm2026-08-17
excluded packagepackage70771-101470771-1014-9DDiscontinued by firm2026-08-17

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 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70771-1014-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70771-1014-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70771-1014-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1014-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1014-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1014-1f5e01cc5f278…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-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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208961-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2017-12-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208961-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2017-12-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208961-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2017-12-271e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208961-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208961-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208961-001AB11e350fbaab3a…

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
Clomipramine HydrochlorideCLOMIPRAMINE HYDROCHLORIDENorthstar Rx LLC.b1809cb2-c6a8-451a-b692-506456c4efc32022-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208961
application number: ANDA208961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1014-170771101401100 CAPSULE in 1 BOTTLE (70771-1014-1) 100 capsule2018-05-030000-00-00NoNoCurrent
70771-1014-77077110140730 CAPSULE in 1 BOTTLE (70771-1014-7) 30 capsule2018-05-030000-00-00NoNoCurrent
70771-1014-97077110140990 CAPSULE in 1 BOTTLE (70771-1014-9) 90 capsule2018-05-030000-00-00NoNoCurrent