Imipramine Hydrochloride

Product NDC
69584-426
11-digit product format
695840426
Labeler code
69584
Product ID
69584-426_1509ebac-0e7d-4b02-ba2e-bf188a26fd77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Oxford Pharmaceuticals, LLC
Application
ANDA040751
Marketing category
ANDA
Marketing start
2020-08-01
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Imipramine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMIPRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BKE5Q1J60UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
835564Internal RxNorm lookup
835568Internal RxNorm lookup
835593Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a5f60cf1-6f14-40a3-a794-9d69b28088d8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a0e0df1b-51aa-4301-873c-732ab0ec1631Product name120170614
0c52f100-e529-4cfc-bd59-334f3eea0233Product name120151110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69584-426-10Imipramine Hydrochloride100 in 1 BOTTLETABLET1006
69584-426-90Imipramine Hydrochloride1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-426-10EA - Each69584-4267e3ec9d7-89f1-498d-9355-0c1d62e53a1012020-08-06
69584-426-90EA - Each69584-4264508b071-833b-4a7c-a47a-3a3d7c6a213112022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-426IMIPRAMINE HYDROCHLORIDE TABLET [OXFORD PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20220608_a5f60cf1-6f14-40a3-a794-9d69b28088d8.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
ndc (product): 69584-426
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
835593imipramine HCl 10 MG Oral TabletPSN830cb1cb-20a1-4617-a748-24241257a24411
835564imipramine HCl 25 MG Oral TabletPSN830cb1cb-20a1-4617-a748-24241257a24411
835568imipramine HCl 50 MG Oral TabletPSN830cb1cb-20a1-4617-a748-24241257a24411
835593imipramine hydrochloride 10 MG Oral TabletSCD830cb1cb-20a1-4617-a748-24241257a24411
835564imipramine hydrochloride 25 MG Oral TabletSCD830cb1cb-20a1-4617-a748-24241257a24411
835568imipramine hydrochloride 50 MG Oral TabletSCD830cb1cb-20a1-4617-a748-24241257a24411
835593imipramine HCl 10 MG Oral TabletPSNa5f60cf1-6f14-40a3-a794-9d69b28088d86
835564imipramine HCl 25 MG Oral TabletPSNa5f60cf1-6f14-40a3-a794-9d69b28088d86
835568imipramine HCl 50 MG Oral TabletPSNa5f60cf1-6f14-40a3-a794-9d69b28088d86
835593imipramine hydrochloride 10 MG Oral TabletSCDa5f60cf1-6f14-40a3-a794-9d69b28088d86
835564imipramine hydrochloride 25 MG Oral TabletSCDa5f60cf1-6f14-40a3-a794-9d69b28088d86
835568imipramine hydrochloride 50 MG Oral TabletSCDa5f60cf1-6f14-40a3-a794-9d69b28088d86
835564imipramine HCl 25 MG Oral TabletPSN02c19a0a-3d9d-4881-ad14-1687aafd87b55
835564imipramine hydrochloride 25 MG Oral TabletSCD02c19a0a-3d9d-4881-ad14-1687aafd87b55
835593imipramine HCl 10 MG Oral TabletPSN5997822f-ce83-4091-be71-21a6b01caaba1
835564imipramine HCl 25 MG Oral TabletPSN5997822f-ce83-4091-be71-21a6b01caaba1
835568imipramine HCl 50 MG Oral TabletPSN5997822f-ce83-4091-be71-21a6b01caaba1
835593imipramine hydrochloride 10 MG Oral TabletSCD5997822f-ce83-4091-be71-21a6b01caaba1
835564imipramine hydrochloride 25 MG Oral TabletSCD5997822f-ce83-4091-be71-21a6b01caaba1
835568imipramine hydrochloride 50 MG Oral TabletSCD5997822f-ce83-4091-be71-21a6b01caaba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69584-426-1069584042610100 TABLET in 1 BOTTLE (69584-426-10) 100 tablet2020-08-010000-00-00NoNoCurrent
69584-426-90695840426901000 TABLET in 1 BOTTLE (69584-426-90) 1000 tablet2022-05-150000-00-00NoNoCurrent