Home NDC 55289-144 Imipramine Hydrochloride
Product NDC 55289-144
11-digit product format 552890144
Labeler code 55289
Product ID 55289-144_d2318b48-11bb-de58-e053-2995a90aba4c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imipramine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA083745
Marketing category ANDA
Marketing start 1976-04-20
Marketing end 0000-00-00
Substance IMIPRAMINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A083745-001 IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A083745-001 AB
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A083745-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB Approved before 1982 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IMIPRAMINE HYDROCHLORIDE ACTIVE INGREDIENT BKE5Q1J60U IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 IMIPRAMINE ACTIVE MOIETY OGG85SX4E4 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 POVIDONE INACTIVE INGREDIENT FZ989GH94E IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-144-14 55289014414 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-144-14) 2011-10-13 0000-00-00 No No Current 55289-144-30 55289014430 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-144-30) 2011-10-13 0000-00-00 No No Current 55289-144-90 55289014490 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-144-90) 2011-10-13 0000-00-00 No No Current