Clomipramine Hydrochloride

Product NDC
0781-2047
11-digit product format
007812047
Labeler code
0781
Product ID
0781-2047_24d4155e-048f-48ad-a7da-21b926f5a830
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA074364
Marketing category
ANDA
Marketing start
1996-03-29
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
2019-12-31
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 productproduct0781-2047DDiscontinued by firm2026-08-17
excluded packagepackage0781-20470781-2047-01DDiscontinued by firm2026-08-17
excluded packagepackage0781-20470781-2047-10DDiscontinued by firm2026-08-17
excluded packagepackage0781-20470781-2047-31DDiscontinued 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 · 48 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 packagepackage0781-2047-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-2047-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-2047-31d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-2047-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-2047-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-2047-31f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-2047-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-2047-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-2047-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-2047-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-2047-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-2047-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-2047-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-2047-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-2047-31cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-2047-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-2047-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-2047-31cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-2047-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-2047-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-2047-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-2047-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-2047-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-2047-31ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-2047-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-2047-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-2047-310efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-2047-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-2047-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-2047-31ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-2047-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-2047-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-2047-31367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-2047-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-2047-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-2047-31557ba5c1ecfa…9c80585c8c6e…

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
A074364-001CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-29
A074364-002CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-29
A074364-003CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074364-001AB
A074364-002AB
A074364-003AB

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 06:07:402026-07A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074364-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074364-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074364-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-03-291e350fbaab3a…

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 06:07:402026-07A074364-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074364-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074364-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074364-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074364-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074364-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074364-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074364-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074364-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074364-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074364-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074364-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074364-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074364-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074364-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074364-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074364-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074364-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074364-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074364-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074364-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074364-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074364-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074364-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074364-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074364-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074364-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074364-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074364-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074364-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074364-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074364-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074364-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074364-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074364-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074364-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074364-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074364-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074364-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074364-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2047-01EA - Each0781-20477d040f2e-987e-4f39-a872-33d96de1bd7212012-07-24