Imipramine Hydrochloride

Product NDC
50436-2022
Requested package NDC
50436-2022-1
11-digit product format
504362022
Labeler code
50436
Product ID
50436-2022_ebfea991-9fd2-46bc-8ff2-aceed31bc3d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040751
Marketing category
ANDA
Marketing start
2022-07-18
Marketing end
0000-00-00
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
25 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50436-202250436-2022-1IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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
A040751-001IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-28
A040751-002IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-28
A040751-003IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040751-001AB
A040751-002AB
A040751-003AB

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 06:07:402026-07A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040751-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2008-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040751-003IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2008-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040751-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2008-02-281e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040751-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040751-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040751-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040751-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040751-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040751-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040751-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040751-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040751-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040751-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040751-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040751-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040751-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040751-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040751-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040751-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040751-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040751-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040751-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040751-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040751-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040751-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040751-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040751-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040751-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040751-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040751-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040751-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040751-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040751-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040751-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040751-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040751-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040751-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040751-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040751-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040751-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040751-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040751-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040751-001AB11e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0e0df1b-51aa-4301-873c-732ab0ec1631Product name120170614
0c52f100-e529-4cfc-bd59-334f3eea0233Product name120151110

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-2022-12024-01-30C16284748780-11030e365-2276-111a-e063-dadaa90a10e2IMIPRAMINE HYDROCHLORIDE
50436-2022-22024-01-30C16284748780-11030e365-2276-111a-e063-dadaa90a10e2IMIPRAMINE HYDROCHLORIDE
50436-2022-32024-01-30C16284748780-11030e365-2276-111a-e063-dadaa90a10e2IMIPRAMINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-2022-1Imipramine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
50436-2022-2Imipramine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
50436-2022-3Imipramine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-2022-1EA - Each50436-20228a4531bc-ab76-4543-b70a-092b988b588d12022-08-04
50436-2022-2EA - Each50436-202226c31f00-afb2-4b89-aad0-174fb937288a12022-08-04
50436-2022-3EA - Each50436-2022b49c8352-262d-43e6-a239-46452c37881012022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-2022IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 3 package rows20220803_b59101e9-b513-4c52-8024-1f8bea700210.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.830cb1cb-20a1-4617-a748-24241257a2442026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040751
application number: ANDA040751
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEREMEDYREPACK INC.02c19a0a-3d9d-4881-ad14-1687aafd87b52026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040751
application number: ANDA040751
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEOxford Pharmaceuticals, LLCa5f60cf1-6f14-40a3-a794-9d69b28088d82026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040751
application number: ANDA040751
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEProficient Rx LP5997822f-ce83-4091-be71-21a6b01caaba2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040751
application number: ANDA040751
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCfd78fb8e-99ae-91b0-e053-6394a90a92712024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040751
application number: ANDA040751
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEKey Therapeutics9c685c94-64cd-442a-ade7-193c62d7a0582024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040751
application number: ANDA040751
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.209cc339-658a-577a-e063-6394a90a2b472024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040751
application number: ANDA040751

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835564imipramine HCl 25 MG Oral TabletPSNb59101e9-b513-4c52-8024-1f8bea7002102
835564imipramine hydrochloride 25 MG Oral TabletSCDb59101e9-b513-4c52-8024-1f8bea7002102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-2022-15043620220130 TABLET, FILM COATED in 1 BOTTLE (50436-2022-1) 2022-07-180000-00-00NoNoCurrent