FDA.reportPublic FDA data

NDC 80425-0294-02 - Imipramine hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0294
Requested NDC
80425-0294-02
Package NDCs from labels
80425-0294-1, 80425-0294-2, 80425-0294-3, 80425-0294-02
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Imipramine hydrochloride - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0294-1Imipramine hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
80425-0294-2Imipramine hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
80425-0294-3Imipramine hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0294IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f887062a-7c82-664f-e053-6294a90a2773.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0294-1EA - Each80425-02940ec4b13f-39d3-4b14-ae64-736e80b4dc0e12023-06-06
80425-0294-2EA - Each80425-02945e9beb98-7776-416b-959c-c020cd32e08812023-06-06
80425-0294-3EA - Each80425-0294ab97ad20-b758-4468-8eb2-55d933bc111c12023-06-06

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 ยท 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDELeading Pharma, LLC490263ce-b4d2-428a-87da-fcd07f85499a2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040903
ndc (product): 69315-133
rxcui: 835593
rxcui: 835564
rxcui: 835568
spl id: 228e6710-c359-4091-aca0-3d0c68ae706b
spl set id: 490263ce-b4d2-428a-87da-fcd07f85499a
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.830cb1cb-20a1-4617-a748-24241257a2442026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835593
rxcui: 835564
rxcui: 835568
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEREMEDYREPACK INC.02c19a0a-3d9d-4881-ad14-1687aafd87b52026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835564
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEStrides Pharma Science Limited51d3b181-0d15-4782-a966-feb137972b182026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835593
rxcui: 835564
rxcui: 835568
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEA-S Medication Solutionsd9dbcebe-9aba-4a93-a7b7-48d29e07d3c42026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040903
rxcui: 835564
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEBryant Ranch Prepackbcd3b62a-88d4-49eb-b0aa-71e28cf409192026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040903
rxcui: 835593
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEOxford Pharmaceuticals, LLCa5f60cf1-6f14-40a3-a794-9d69b28088d82026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835593
rxcui: 835564
rxcui: 835568
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEREMEDYREPACK INC.db007ac0-020e-4962-8903-7497ab96a74e2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040903
rxcui: 835568
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDECoupler LLC48e8b819-a9a0-aa5a-e063-6394a90ad9c22026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040903
rxcui: 835564
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEProficient Rx LP5997822f-ce83-4091-be71-21a6b01caaba2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835593
rxcui: 835564
rxcui: 835568
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEBryant Ranch Prepack20af582f-08ba-4281-a2df-0bcf68c585942025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040903
rxcui: 835564
unii: BKE5Q1J60U
Imipramine hydrochlorideIMIPRAMINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf887062a-7c82-664f-e053-6294a90a27732024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040903
ndc (package): 80425-0294-2
ndc (package): 80425-0294-3
ndc (package): 80425-0294-1
ndc (product): 80425-0294
ndc11 (package): 80425029402
rxcui: 835593
spl id: 2a9bad62-b304-697c-e063-6294a90aa395
spl set id: f887062a-7c82-664f-e053-6294a90a2773
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCfd78fb8e-99ae-91b0-e053-6394a90a92712024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835564
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEKey Therapeutics9c685c94-64cd-442a-ade7-193c62d7a0582024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835564
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.209cc339-658a-577a-e063-6394a90a2b472024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835568
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDELupin Pharmaceuticals, Inc.55311747-710c-43c4-821d-76323ff2520e2023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835593
rxcui: 835564
rxcui: 835568
unii: BKE5Q1J60U
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEProficient Rx LP3f90b8dd-7234-4428-b896-943d052dd05f2023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040903
rxcui: 835593
unii: BKE5Q1J60U

Reported adverse events (FAERS/openFDA)#

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