Home NDC 72789-492-01 Imipramine Hydrochloride
Product NDC 72789-492
Requested package NDC 72789-492-01
11-digit product format 727890492
Labeler code 72789
Product ID 72789-492_5b8b76f8-b753-3aa4-e063-6294a90a9541
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imipramine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040903-001 IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 A040903-002 IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 A040903-003 IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 135 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-11-14 07:37:17 2026-10 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040903-002 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2012-10-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040903-003 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2012-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040903-001 IMIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-10-24 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 135 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Imipramine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IMIPRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BKE5Q1J60U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 835564 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72789-492-01 Imipramine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 19 72789-492-95 Imipramine Hydrochloride 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-492 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 16 Current NDC, 2 package rows 20250312_649837df-147f-436c-9553-32ffecf4c6f1.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Imipramine Hydrochloride IMIPRAMINE HYDROCHLORIDE Leading Pharma, LLC 490263ce-b4d2-428a-87da-fcd07f85499a 2026-08-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040903 application number: ANDA040903 Imipramine Hydrochloride IMIPRAMINE HYDROCHLORIDE A-S Medication Solutions d9dbcebe-9aba-4a93-a7b7-48d29e07d3c4 2026-06-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040903 application number: ANDA040903 Imipramine Hydrochloride IMIPRAMINE HYDROCHLORIDE Coupler LLC 48e8b819-a9a0-aa5a-e063-6394a90ad9c2 2026-01-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040903 application number: ANDA040903 Imipramine hydrochloride IMIPRAMINE HYDROCHLORIDE Advanced Rx Pharmacy of Tennessee, LLC f887062a-7c82-664f-e053-6294a90a2773 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040903 application number: ANDA040903 Imipramine Hydrochloride IMIPRAMINE HYDROCHLORIDE Proficient Rx LP 3f90b8dd-7234-4428-b896-943d052dd05f 2023-06-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040903 application number: ANDA040903
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72789-492-01 72789049201 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-492-01) 2025-03-10 No No Current