FDA.reportPublic FDA data

Clomipramine Hydrochloride

Product NDC
72664-216
11-digit product format
726640216
Labeler code
72664
Product ID
72664-216_c5721d3a-16d2-c1e1-e053-2a95a90a2189
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
VGYAAN Pharmaceuticals LLC
Application
ANDA213221
Marketing category
ANDA
Marketing start
2021-07-01
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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72664-216IInactivated by FDA2026-10-16
excluded packagepackage72664-21672664-216-30IInactivated by FDA2026-10-16
excluded packagepackage72664-21672664-216-90IInactivated by FDA2026-10-16

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A213221-001CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22
A213221-002CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22
A213221-003CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22

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 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22c2088c7a36db…
2026-10-15 13:18:302026-09A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22c2088c7a36db…
2026-10-15 13:18:302026-09A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22c2088c7a36db…
2026-09-14 22:38:342026-08A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-2284e616aacf4f…
2026-09-14 22:38:342026-08A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-2284e616aacf4f…
2026-09-14 22:38:342026-08A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-2284e616aacf4f…
2026-08-18 06:07:402026-07A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A213221-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A213221-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213221-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-06-2279d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-01-26 05:58 UTC2023-01A213221-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A213221-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213221-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213221-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213221-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213221-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A213221-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A213221-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213221-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A213221-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A213221-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213221-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213221-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213221-003AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

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

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
72664-216-302026-01-29C16284748780-149896155-bec6-586f-e063-e6dba90add90Clomipramine Hydrochloride Capsules, USP 25 mg, 50 mg and 75 mg. Rx Only
72664-216-902026-01-29C16284748780-149896155-bec6-586f-e063-e6dba90add90Clomipramine Hydrochloride Capsules, USP 25 mg, 50 mg and 75 mg. Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72664-216-30Clomipramine Hydrochloride30 in 1 BOTTLECAPSULE308
72664-216-90Clomipramine Hydrochloride90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72664-216-90EA - Each72664-2160e1bc63e-ece0-4b50-8b7a-2f298bc0a01c12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72664-216CLOMIPRAMINE HYDROCHLORIDE CAPSULE [VGYAAN PHARMACEUTICALS LLC]8Legacy NDC, 2 package rows20230923_9051b489-eba0-4ffa-a577-6dd9d918285d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSN9051b489-eba0-4ffa-a577-6dd9d918285d8
857301clomiPRAMINE HCl 50 MG Oral CapsulePSN9051b489-eba0-4ffa-a577-6dd9d918285d8
857305clomiPRAMINE HCl 75 MG Oral CapsulePSN9051b489-eba0-4ffa-a577-6dd9d918285d8
857297clomipramine hydrochloride 25 MG Oral CapsuleSCD9051b489-eba0-4ffa-a577-6dd9d918285d8
857301clomipramine hydrochloride 50 MG Oral CapsuleSCD9051b489-eba0-4ffa-a577-6dd9d918285d8
857305clomipramine hydrochloride 75 MG Oral CapsuleSCD9051b489-eba0-4ffa-a577-6dd9d918285d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72664-216-307266402163030 CAPSULE in 1 BOTTLE (72664-216-30) 30 capsule2020-05-170000-00-00NoNoCurrent
72664-216-907266402169090 CAPSULE in 1 BOTTLE (72664-216-90) 90 capsule2020-05-170000-00-00NoNoCurrent