clomiPRAMINE Hydrochloride

Product NDC
10135-698
11-digit product format
101350698
Labeler code
10135
Product ID
10135-698_cd41b705-ed9a-2910-e053-2995a90a6ed5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOMIPRAMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA210653
Marketing category
ANDA
Marketing start
2020-05-01
Marketing end
0000-00-00
Substance
CLOMIPRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10135-698IInactivated by FDA2026-08-17
excluded packagepackage10135-69810135-698-01IInactivated by FDA2026-08-17

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 · 30 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 packagepackage10135-698-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10135-698-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10135-698-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10135-698-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10135-698-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10135-698-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10135-698-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10135-698-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10135-698-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10135-698-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10135-698-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10135-698-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10135-698-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10135-698-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10135-698-011332a3947898…d4bfe170f9cd…

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
A210653-001CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-04-03
A210653-002CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-04-03
A210653-003CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-04-03

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 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-04-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-031e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210653-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210653-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210653-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210653-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210653-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210653-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210653-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210653-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210653-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210653-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210653-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210653-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210653-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210653-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210653-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210653-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210653-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210653-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210653-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210653-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210653-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210653-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210653-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210653-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210653-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210653-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210653-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210653-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210653-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210653-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210653-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210653-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210653-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210653-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210653-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210653-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210653-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210653-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210653-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210653-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06ad84c7-ef7f-2b11-27cb-22ae93f433b6Product name920240422

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-698-012023-01-30C16284748780-1f386c64a-221b-0266-e053-dadaa90a7c1aclomiPRAMINE Hydrochloride Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-698-01clomiPRAMINE Hydrochloride100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-698-01EA - Each10135-698b7d5ce9e-7221-469a-965e-39445888142212020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-698CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MARLEX PHARMACEUTICALS INC]3Legacy NDC, 1 package rows20211003_7a2d0cf1-dabe-430d-90f7-74973cba48e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSN7a2d0cf1-dabe-430d-90f7-74973cba48e33
857301clomiPRAMINE HCl 50 MG Oral CapsulePSN7a2d0cf1-dabe-430d-90f7-74973cba48e33
857305clomiPRAMINE HCl 75 MG Oral CapsulePSN7a2d0cf1-dabe-430d-90f7-74973cba48e33
857297clomipramine hydrochloride 25 MG Oral CapsuleSCD7a2d0cf1-dabe-430d-90f7-74973cba48e33
857301clomipramine hydrochloride 50 MG Oral CapsuleSCD7a2d0cf1-dabe-430d-90f7-74973cba48e33
857305clomipramine hydrochloride 75 MG Oral CapsuleSCD7a2d0cf1-dabe-430d-90f7-74973cba48e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-698-0110135069801100 CAPSULE in 1 BOTTLE (10135-698-01) 100 capsule2020-05-010000-00-00NoNoCurrent