Home NDC 53489-331 Imipramine Hydrochloride
Product NDC 53489-331
11-digit product format 534890331
Labeler code 53489
Product ID 53489-331_9e0586d7-3835-4ee5-9bff-141344f3e611
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imipramine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA081049
Marketing category ANDA
Marketing start 1990-06-05
Marketing end 2020-12-31
Substance IMIPRAMINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 36 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 A081049-001 IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A081049-001 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 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A081049-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1990-06-05 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# 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 [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 Imipramine ACTIVE MOIETY OGG85SX4E4 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 aluminum oxide INACTIVE INGREDIENT LMI26O6933 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 calcium phosphate, dibasic, anhydrous INACTIVE INGREDIENT L11K75P92J IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 D&C red No. 30 INACTIVE INGREDIENT 2S42T2808B IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 D&C yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 FD&C blue No. 1 INACTIVE INGREDIENT H3R47K3TBD IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 FD&C blue No. 2 INACTIVE INGREDIENT L06K8R7DQK IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 FD&C red No. 40 INACTIVE INGREDIENT WZB9127XOA IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 FD&C yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 hydroxypropyl cellulose (type h) INACTIVE INGREDIENT RFW2ET671P IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 magnesium stearate INACTIVE INGREDIENT 70097M6I30 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 13 Imipramine Hydrochloride ACTIVE INGREDIENT BKE5Q1J60U IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 Imipramine ACTIVE MOIETY OGG85SX4E4 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 aluminum oxide INACTIVE INGREDIENT LMI26O6933 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 calcium phosphate, dibasic, anhydrous INACTIVE INGREDIENT L11K75P92J IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 FD&C blue No. 2 INACTIVE INGREDIENT L06K8R7DQK IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 FD&C red No. 40 INACTIVE INGREDIENT WZB9127XOA IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 FD&C yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC] 1
DailyMed RxNorm Mappings#