Amitriptyline Hydrochloride
- Product NDC
- 80425-0285
- 11-digit product format
- 804250285
- Labeler code
- 80425
- Product ID
- 80425-0285_2a9b9724-0256-e829-e063-6394a90a1c07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA214548
- Marketing category
- ANDA
- Marketing start
- 2023-03-22
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | 80425-0285 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 80425-0285 | 80425-0285-1 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 80425-0285 | 80425-0285-2 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 80425-0285 | 80425-0285-3 | D | Discontinued by firm | 2026-10-12 |
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 | 80425-0285-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 80425-0285-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 80425-0285-2 | 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 | 80425-0285-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 80425-0285-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 80425-0285-2 | 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 | 80425-0285-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 80425-0285-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 80425-0285-2 | 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 | 80425-0285-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 80425-0285-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 80425-0285-2 | 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 | 80425-0285-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 80425-0285-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 80425-0285-2 | 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 | 80425-0285-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 80425-0285-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 80425-0285-2 | 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 | 80425-0285-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 80425-0285-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 80425-0285-2 | 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 | 80425-0285-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 80425-0285-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 80425-0285-2 | 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 | 80425-0285-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 80425-0285-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 80425-0285-2 | 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 | 80425-0285-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 80425-0285-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 80425-0285-2 | 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 | 80425-0285-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 80425-0285-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 80425-0285-2 | 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 | 80425-0285-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 80425-0285-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 80425-0285-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | |
| A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | |
| A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | |
| A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | |
| A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | |
| A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214548-001 | AB |
| A214548-002 | AB |
| A214548-003 | AB |
| A214548-004 | AB |
| A214548-005 | AB |
| A214548-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2021-05-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2021-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2021-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2021-05-19 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214548-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214548-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214548-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214548-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214548-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214548-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A214548-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214548-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214548-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214548-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214548-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214548-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214548-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214548-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214548-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214548-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214548-004 | AB | 1 | b8a1b40f171c… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amitriptyline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 26LUD4JO9K | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 856834 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f98d25a7-6b47-38a9-e053-6394a90a541d | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e5006e90-7f2e-4341-bcdb-f83027a8fc39 | Product name | 6 | 20240611 |
| 6f1277d7-db3a-63fa-be84-d390d1482706 | Product name | 1 | 20140508 |
| aa9828b2-adf8-0dd3-9f6c-b68f39e467c1 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0285-1 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 2 | |
| 80425-0285-2 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 2 | |
| 80425-0285-3 | Amitriptyline 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 |
|---|---|---|---|---|---|
| 80425-0285-1 | EA - Each | 80425-0285 | 8ac05c3c-7f53-4840-8b14-ed9eccf20378 | 1 | 2023-04-07 |
| 80425-0285-2 | EA - Each | 80425-0285 | 45e21b2d-7df6-4726-bcde-f24762b34bf5 | 1 | 2023-06-06 |
| 80425-0285-3 | EA - Each | 80425-0285 | a3757cef-b1c8-4e1c-b8a8-46487d0f84fe | 1 | 2023-06-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0285 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 3 package rows | 20250102_f98d25a7-6b47-38a9-e053-6394a90a541d.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 |
|---|---|---|---|---|---|---|
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 2bda8478-f5ab-440a-a8a3-61ebc5721369 | 2025-05-16 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 86bad1a5-48c3-4a8a-970f-8fdbda078b4e | 2025-05-15 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline HCL | AMITRIPTYLINE HCL | Direct_Rx | 3504be24-1e75-5e68-e063-6294a90a270a | 2025-05-13 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | bbbd535d-0bce-469e-917f-70a6ebd2f007 | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 69c7a0bd-93d0-40fe-a6d3-f41986b802b4 | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| AMITRIPTYLINE HCL | AMITRIPTYLINE HCL | Direct_Rx | f420498a-bfcc-4549-e053-2995a90a7b09 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline HCL | AMITRIPTYLINE HCL | Direct_Rx | f6dc463b-3601-48c0-e053-6294a90a2d77 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | AvPAK | f5c5f3b6-e92b-1120-e053-2995a90ae8fa | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | AvPAK | fd771b4b-c7ae-8e69-e053-6294a90a2120 | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 082b620f-8085-d205-e063-6294a90ac6de | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f98d25a7-6b47-38a9-e053-6394a90a541d | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 80425-0285 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f78102eb-cbeb-801a-e053-6294a90ab880 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 8c9f605f-ac13-442f-af4d-ea11102474de | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | ac1a7640-58d7-494d-94c8-27911470bf59 | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 6a176cd7-7c13-440e-b6bb-dc2fab3f2a12 | 2024-08-16 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 18ff2901-08fd-37f0-e063-6394a90a1ad2 | 2024-05-21 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | ce665435-b2f1-4fcd-ae20-4f372f376095 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Asclemed USA, Inc. | 776d2c2c-d897-4da1-a99a-b4324e1f864f | 2024-03-02 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 61133866-b01c-4278-93fb-4564c1b56e54 | 2024-03-01 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 00d11130-c9ae-4258-9746-9763bc5deb84 | 2023-12-22 | Boxed warning, Warnings, Adverse reactions | 214548 ANDA214548 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | f98d25a7-6b47-38a9-e053-6394a90a541d | 2 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | f98d25a7-6b47-38a9-e053-6394a90a541d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 80425-0285-1 | 80425028501 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0285-1) | 2023-03-22 | No | No | Current |
| 80425-0285-2 | 80425028502 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0285-2) | 2023-03-22 | No | No | Current |
| 80425-0285-3 | 80425028503 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0285-3) | 2023-03-22 | No | No | Current |