Home NDC 68071-2730-9 Imipramine Hydrochloride
Product NDC 68071-2730
Requested package NDC 68071-2730-9
11-digit product format 680712730
Labeler code 68071
Product ID 68071-2730_dfb479a9-d6da-d36d-e053-2a95a90ae4f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imipramine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA088276
Marketing category ANDA
Marketing start 1983-10-21
Marketing end 0000-00-00
Substance IMIPRAMINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 A088276-001 IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088276-001 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 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088276-001 IMIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1983-10-21 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-2730-9 68071273009 90 TABLET in 1 BOTTLE (68071-2730-9) 90 tablet 2022-05-23 0000-00-00 No No Current