Imipramine Hydrochloride

Product NDC
69315-135
Requested package NDC
69315-135-10
11-digit product format
693150135
Labeler code
69315
Product ID
69315-135_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
50 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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMIPRAMINE HYDROCHLORIDE50 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
69315-135-01Imipramine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10019
69315-135-10Imipramine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-135-01EA - Each69315-1358a22e933-2b12-4cac-b7aa-d0500c710bec12016-05-16
69315-135-10EA - Each69315-1357225f551-827a-4e94-9320-9647591f509312016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-135IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LEADING PHARMA, LLC]16Current NDC, Legacy NDC, 2 package rows20250331_490263ce-b4d2-428a-87da-fcd07f85499a.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 · 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): 69315-135-10
ndc (product): 69315-135
ndc11 (package): 69315013510
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

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
835568imipramine HCl 50 MG Oral TabletPSN490263ce-b4d2-428a-87da-fcd07f85499a19
835568imipramine HCl 50 MG Oral TabletPSN7091ff32-55b9-48fd-a86d-c502af57473f19
835593imipramine hydrochloride 10 MG Oral TabletSCD490263ce-b4d2-428a-87da-fcd07f85499a19
835564imipramine hydrochloride 25 MG Oral TabletSCD490263ce-b4d2-428a-87da-fcd07f85499a19
835568imipramine hydrochloride 50 MG Oral TabletSCD490263ce-b4d2-428a-87da-fcd07f85499a19
835568imipramine hydrochloride 50 MG Oral TabletSCD7091ff32-55b9-48fd-a86d-c502af57473f19
835568imipramine HCl 50 MG Oral TabletPSNdb007ac0-020e-4962-8903-7497ab96a74e13
835568imipramine hydrochloride 50 MG Oral TabletSCDdb007ac0-020e-4962-8903-7497ab96a74e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69315-135-10693150135101000 TABLET, FILM COATED in 1 BOTTLE (69315-135-10) 2016-05-010000-00-00NoNoCurrent