Imipramine Hydrochloride
- Product NDC
- 50436-2022
- 11-digit product format
- 504362022
- Labeler code
- 50436
- Product ID
- 50436-2022_ebfea991-9fd2-46bc-8ff2-aceed31bc3d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Imipramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA040751
- Marketing category
- ANDA
- Marketing start
- 2022-07-18
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 50436-2022 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 50436-2022 | 50436-2022-1 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 50436-2022 | 50436-2022-2 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 50436-2022 | 50436-2022-3 | I | Inactivated by FDA | 2026-08-17 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50436-2022-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50436-2022-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50436-2022-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50436-2022-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50436-2022-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50436-2022-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50436-2022-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50436-2022-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50436-2022-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50436-2022-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50436-2022-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50436-2022-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50436-2022-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50436-2022-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50436-2022-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50436-2022-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50436-2022-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50436-2022-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50436-2022-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50436-2022-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50436-2022-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50436-2022-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50436-2022-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50436-2022-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50436-2022-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50436-2022-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50436-2022-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50436-2022-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50436-2022-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50436-2022-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50436-2022-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50436-2022-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50436-2022-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50436-2022-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50436-2022-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50436-2022-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50436-2022-3 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50436-2022-2 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50436-2022-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50436-2022-3 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50436-2022-2 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50436-2022-1 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50436-2022-3 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50436-2022-2 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50436-2022-1 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040751-001 | IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | |
| A040751-002 | IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | |
| A040751-003 | IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040751-001 | AB |
| A040751-002 | AB |
| A040751-003 | 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.
| 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 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040751-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-02-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040751-003 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-02-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040751-001 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-02-28 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040751-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040751-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040751-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040751-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040751-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040751-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040751-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040751-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040751-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040751-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040751-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040751-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040751-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040751-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040751-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040751-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040751-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040751-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040751-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040751-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040751-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040751-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040751-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040751-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040751-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040751-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040751-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040751-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040751-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040751-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040751-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040751-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040751-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040751-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040751-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040751-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040751-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040751-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040751-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040751-001 | AB | 1 | 1e350fbaab3a… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a0e0df1b-51aa-4301-873c-732ab0ec1631 | Product name | 1 | 20170614 |
| 0c52f100-e529-4cfc-bd59-334f3eea0233 | Product name | 1 | 20151110 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-2022-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2276-111a-e063-dadaa90a10e2 | IMIPRAMINE HYDROCHLORIDE |
| 50436-2022-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2276-111a-e063-dadaa90a10e2 | IMIPRAMINE HYDROCHLORIDE |
| 50436-2022-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2276-111a-e063-dadaa90a10e2 | IMIPRAMINE HYDROCHLORIDE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-2022-1 | Imipramine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 2 | |
| 50436-2022-2 | Imipramine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 2 | |
| 50436-2022-3 | Imipramine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-2022-1 | EA - Each | 50436-2022 | 8a4531bc-ab76-4543-b70a-092b988b588d | 1 | 2022-08-04 |
| 50436-2022-2 | EA - Each | 50436-2022 | 26c31f00-afb2-4b89-aad0-174fb937288a | 1 | 2022-08-04 |
| 50436-2022-3 | EA - Each | 50436-2022 | b49c8352-262d-43e6-a239-46452c378810 | 1 | 2022-08-04 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-2022 | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | Legacy NDC, 3 package rows | 20220803_b59101e9-b513-4c52-8024-1f8bea700210.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 830cb1cb-20a1-4617-a748-24241257a244 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 040751 ANDA040751 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | REMEDYREPACK INC. | 02c19a0a-3d9d-4881-ad14-1687aafd87b5 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 040751 ANDA040751 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | Oxford Pharmaceuticals, LLC | a5f60cf1-6f14-40a3-a794-9d69b28088d8 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 040751 ANDA040751 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | Proficient Rx LP | 5997822f-ce83-4091-be71-21a6b01caaba | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 040751 ANDA040751 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | fd78fb8e-99ae-91b0-e053-6394a90a9271 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 040751 ANDA040751 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | Key Therapeutics | 9c685c94-64cd-442a-ade7-193c62d7a058 | 2024-10-09 | Boxed warning, Warnings, Adverse reactions | 040751 ANDA040751 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 209cc339-658a-577a-e063-6394a90a2b47 | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | 040751 ANDA040751 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 835564 | imipramine HCl 25 MG Oral Tablet | PSN | b59101e9-b513-4c52-8024-1f8bea700210 | 2 |
| 835564 | imipramine hydrochloride 25 MG Oral Tablet | SCD | b59101e9-b513-4c52-8024-1f8bea700210 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50436-2022-1 | 50436202201 | 30 TABLET, FILM COATED in 1 BOTTLE (50436-2022-1) | 2022-07-18 | 0000-00-00 | No | No | Current |
| 50436-2022-2 | 50436202202 | 60 TABLET, FILM COATED in 1 BOTTLE (50436-2022-2) | 2022-07-18 | 0000-00-00 | No | No | Current |
| 50436-2022-3 | 50436202203 | 90 TABLET, FILM COATED in 1 BOTTLE (50436-2022-3) | 2022-07-18 | 0000-00-00 | No | No | Current |