CLOMIPRAMINE HYDROCHLORIDE

Product NDC
68084-790
Requested package NDC
68084-790-25
11-digit product format
680840790
Labeler code
68084
Product ID
68084-790_25133505-fbef-95cb-e063-6394a90a2aae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA074694
Marketing category
ANDA
Marketing start
2016-02-01
Substance
CLOMIPRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074694-001CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-31
A074694-002CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-31
A074694-003CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074694-001AB
A074694-002AB
A074694-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074694-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB1996-12-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074694-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB1996-12-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074694-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB1996-12-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074694-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074694-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074694-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074694-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074694-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074694-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074694-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074694-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074694-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074694-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074694-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074694-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074694-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074694-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074694-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074694-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074694-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074694-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074694-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074694-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074694-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074694-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074694-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074694-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074694-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074694-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074694-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074694-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074694-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074694-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074694-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074694-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074694-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074694-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074694-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074694-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074694-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074694-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074694-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074694-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
CLOMIPRAMINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOMIPRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2LXW0L6GWJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
857297Internal RxNorm lookup
857301Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1809bcb4-5fcc-45ca-986a-4fa5edcd4b5eAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-790-25CLOMIPRAMINE HYDROCHLORIDE30 in 1 BOX, UNIT-DOSECAPSULE307
68084-790-95CLOMIPRAMINE HYDROCHLORIDE1 in 1 BLISTER PACKCAPSULE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-790-11EA - Each68084-790b13d2dd9-b979-42e1-8f5c-84b5f75e30fb12014-11-05
68084-790-21EA - Each68084-790b28efd19-9f12-42b5-8ef5-06dd87c2aba512014-11-05
68084-790-25EA - Each68084-790956cb07f-e5ba-4a0c-8028-3df6fafa635112016-03-04
68084-790-95EA - Each68084-790df1d919b-5e13-4ac2-bdb2-8844b103ae3512016-03-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-790CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20241025_1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEMajor Pharmaceuticalseff91018-5a5e-4426-96ae-71ecd82273b72025-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074694
application number: ANDA074694
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEGolden State Medical Supply, Inc.fa2eb38c-b155-0d53-e053-6294a90a1d292025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074694
application number: ANDA074694
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.db752dbd-be41-4cdd-8a13-ed1ff9ef74612025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074694
application number: ANDA074694
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAmerican Health Packaging1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074694
application number: ANDA074694
ndc (package): 68084-790-25
ndc (product): 68084-790
ndc11 (package): 68084079025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSN1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e7
857301clomiPRAMINE HCl 50 MG Oral CapsulePSN1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e7
857297clomipramine hydrochloride 25 MG Oral CapsuleSCD1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e7
857301clomipramine hydrochloride 50 MG Oral CapsuleSCD1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-790-256808407902530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-790-25) / 1 CAPSULE in 1 BLISTER PACK (68084-790-95) 30 blister pack2016-02-010000-00-00NoNoCurrent