AMITRIPTYLINE HYDROCHLORIDE
- Product NDC
- 55700-643
- 11-digit product format
- 557000643
- Labeler code
- 55700
- Product ID
- 55700-643_1af9bb31-c636-416c-92e2-ed5f70542972
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMITRIPTYLINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA202446
- Marketing category
- ANDA
- Marketing start
- 2018-06-22
- Marketing end
- 0000-00-00
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 10 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 | 55700-643 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 55700-643 | 55700-643-30 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 55700-643 | 55700-643-90 | D | Discontinued by firm | 2026-08-11 |
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 | 55700-643-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-643-30 | 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 | 55700-643-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-643-30 | 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 | 55700-643-90 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-643-30 | 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 | 55700-643-90 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-643-30 | 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 | 55700-643-90 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-643-30 | 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 | 55700-643-90 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55700-643-30 | 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 | 55700-643-90 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55700-643-30 | 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 | 55700-643-90 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55700-643-30 | 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 | 55700-643-90 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 55700-643-30 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | |
| A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | |
| A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | |
| A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | |
| A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | |
| A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202446-001 | AB |
| A202446-002 | AB |
| A202446-003 | AB |
| A202446-004 | AB |
| A202446-005 | AB |
| A202446-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202446-005 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2014-06-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202446-006 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2014-06-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202446-001 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202446-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-06-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202446-003 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-06-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202446-004 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2014-06-04 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202446-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202446-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202446-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202446-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202446-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202446-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202446-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202446-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202446-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202446-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202446-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202446-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202446-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202446-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202446-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202446-004 | AB | 1 | 2680178bc6a6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-643-30 | EA - Each | 55700-643 | c54176af-5882-4b33-862b-a4d06167c304 | 1 | 2018-08-13 |
| 55700-643-90 | EA - Each | 55700-643 | 29f853c7-c9b1-4659-8bd9-fb8c2a8beb6b | 1 | 2018-08-13 |
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 | Northwind Health Company, LLC | e3afe026-7072-0a7d-e053-2995a90a52d4 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 |
| Amitriptyline HCL | AMITRIPTYLINE HCL | Advanced Rx Pharmacy of Tennessee, LLC | ca66c2fc-6724-f4cd-e053-2995a90a42cf | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 76d3f4fd-4603-4cfc-94ab-2e62c0bdae75 | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 58ff9a82-5de6-a1b0-e053-2991aa0a84ba | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 5a5a4040-5395-54ac-e053-2991aa0aa4ab | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 9440dd10-2f0d-42a7-a037-3ab8729708f6 | 2023-01-03 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | df5aee40-ffa9-4cf3-ab5f-30253f43092b | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 202446 ANDA202446 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55700-643-30 | 55700064330 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-643-30) | 2018-06-22 | 0000-00-00 | No | No | Current |
| 55700-643-90 | 55700064390 | 90 TABLET, FILM COATED in 1 BOTTLE (55700-643-90) | 2018-06-22 | 0000-00-00 | No | No | Current |