Home NDC 49884-055-10 Imipramine Hydrochloride
Product NDC 49884-055
Requested package NDC 49884-055-10
11-digit product format 498840055
Labeler code 49884
Product ID 49884-055_2e41fb61-bc65-4d6e-99a9-e710d3f12d8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imipramine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA088262
Marketing category ANDA
Marketing start 1983-10-21
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 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 · 11 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…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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 A088262-001 IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 25MG 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 A088262-001 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 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088262-001 IMIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1983-10-21 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 [PAR PHARMACEUTICAL INC.] 10 IMIPRAMINE ACTIVE MOIETY OGG85SX4E4 IMIPRAMINE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 10 IMIPRAMINE HYDROCHLORIDE ACTIVE INGREDIENT BKE5Q1J60U IMIPRAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC] 1 IMIPRAMINE HYDROCHLORIDE ACTIVE INGREDIENT BKE5Q1J60U IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 IMIPRAMINE ACTIVE MOIETY OGG85SX4E4 IMIPRAMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC] 1 IMIPRAMINE ACTIVE MOIETY OGG85SX4E4 IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SODIUM STARCH GLYCOLATE TYPE B POTATO INACTIVE INGREDIENT 27NA468985 IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 IMIPRAMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
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 49884-055-10 49884005510 1000 TABLET in 1 BOTTLE (49884-055-10) 1000 tablet 1983-11-01 0000-00-00 No No Current