Imipramine Hydrochloride

Product NDC
69315-134
Requested package NDC
69315-134-10
11-digit product format
693150134
Labeler code
69315
Product ID
69315-134_2fbbe85e-9a5e-45af-bea7-e2b7ef240d3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA040903
Marketing category
ANDA
Marketing start
2016-04-07
Substance
IMIPRAMINE 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
A040903-001IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24
A040903-002IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24
A040903-003IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040903-001AB
A040903-002AB
A040903-003AB

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 UTC2026-02A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-248072bd15b7f6…

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 UTC2026-02A040903-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040903-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040903-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040903-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040903-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040903-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040903-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040903-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040903-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040903-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040903-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040903-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040903-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040903-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040903-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040903-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040903-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040903-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040903-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040903-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040903-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040903-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040903-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040903-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040903-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040903-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040903-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040903-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040903-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040903-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040903-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040903-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040903-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040903-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040903-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040903-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040903-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040903-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040903-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040903-001AB18072bd15b7f6…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEA-S Medication Solutionsd9dbcebe-9aba-4a93-a7b7-48d29e07d3c42026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7091ff32-55b9-48fd-a86d-c502af57473f2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.649837df-147f-436c-9553-32ffecf4c6f12026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEBryant Ranch Prepackbcd3b62a-88d4-49eb-b0aa-71e28cf409192026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEREMEDYREPACK INC.db007ac0-020e-4962-8903-7497ab96a74e2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDECoupler LLC48e8b819-a9a0-aa5a-e063-6394a90ad9c22026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDELeading Pharma, LLC490263ce-b4d2-428a-87da-fcd07f85499a2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
ndc (package): 69315-134-10
ndc (product): 69315-134
ndc11 (package): 69315013410
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEBryant Ranch Prepack20af582f-08ba-4281-a2df-0bcf68c585942025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine hydrochlorideIMIPRAMINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf887062a-7c82-664f-e053-6294a90a27732024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEProficient Rx LP3f90b8dd-7234-4428-b896-943d052dd05f2023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903

Additional Listing Data#

Finished product
Yes
Brand name base
Imipramine Hydrochloride
Listing expiration
2026-12-31

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
490263ce-b4d2-428a-87da-fcd07f85499aAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-134-01Imipramine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10019
69315-134-10Imipramine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-134-01EA - Each69315-134c8ec02a2-77c2-481d-996a-29984957494212016-05-16
69315-134-10EA - Each69315-1343718de7c-aea6-439a-90c7-a19e4691257012016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-134IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LEADING PHARMA, LLC]16Current NDC, Legacy NDC, 2 package rows20250331_490263ce-b4d2-428a-87da-fcd07f85499a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835593imipramine HCl 10 MG Oral TabletPSN490263ce-b4d2-428a-87da-fcd07f85499a19
835564imipramine HCl 25 MG Oral TabletPSN490263ce-b4d2-428a-87da-fcd07f85499a19
835564imipramine HCl 25 MG Oral TabletPSN649837df-147f-436c-9553-32ffecf4c6f119
835568imipramine HCl 50 MG Oral TabletPSN490263ce-b4d2-428a-87da-fcd07f85499a19
835593imipramine hydrochloride 10 MG Oral TabletSCD490263ce-b4d2-428a-87da-fcd07f85499a19
835564imipramine hydrochloride 25 MG Oral TabletSCD490263ce-b4d2-428a-87da-fcd07f85499a19
835564imipramine hydrochloride 25 MG Oral TabletSCD649837df-147f-436c-9553-32ffecf4c6f119
835568imipramine hydrochloride 50 MG Oral TabletSCD490263ce-b4d2-428a-87da-fcd07f85499a19
835564imipramine HCl 25 MG Oral TabletPSNd9dbcebe-9aba-4a93-a7b7-48d29e07d3c49
835564imipramine hydrochloride 25 MG Oral TabletSCDd9dbcebe-9aba-4a93-a7b7-48d29e07d3c49
835564imipramine HCl 25 MG Oral TabletPSN20af582f-08ba-4281-a2df-0bcf68c585941
835564imipramine HCl 25 MG Oral TabletPSN48e8b819-a9a0-aa5a-e063-6394a90ad9c21
835564imipramine hydrochloride 25 MG Oral TabletSCD20af582f-08ba-4281-a2df-0bcf68c585941
835564imipramine hydrochloride 25 MG Oral TabletSCD48e8b819-a9a0-aa5a-e063-6394a90ad9c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69315-134-10693150134101000 TABLET, FILM COATED in 1 BOTTLE (69315-134-10) 2016-05-010000-00-00NoNoCurrent