Amitriptyline Hydrochloride
- Product NDC
- 0781-1487
- 11-digit product format
- 007811487
- Labeler code
- 0781
- Product ID
- 0781-1487_9df45420-7268-454e-9624-8da48c97b7db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA085968
- Marketing category
- ANDA
- Marketing start
- 1977-11-21
- 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 package | package | 0781-1487 | 0781-1487-31 | D | Discontinued by firm | 2026-08-07 |
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 | 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… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | |
| A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A085968-001 | AB |
| A085968-002 | AB |
| A085968-003 | AB |
| A085968-004 | AB |
| A085968-005 | AB |
| A085968-006 | 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 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-005 | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-006 | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-001 | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-002 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-003 | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-004 | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 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 | A085968-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085968-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085968-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085968-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085968-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085968-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085968-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085968-004 | AB | 1 | 2680178bc6a6… |
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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 705a2bae-031d-4218-82fe-4346542c0baa | 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 0781-1487-01 | 2020-08-18 | Amitriptyline Hydrochloride Tablets, USP |
| 0781-1487-10 | 2020-08-18 | Amitriptyline Hydrochloride Tablets, USP |
| 0781-1487-31 | 2020-08-18 | Amitriptyline Hydrochloride Tablets, USP |
| 0781-1487-01 | 2020-07-22 | Amitriptyline Hydrochloride Tablets, USP |
| 0781-1487-10 | 2020-07-22 | Amitriptyline Hydrochloride Tablets, USP |
| 0781-1487-31 | 2020-07-22 | Amitriptyline Hydrochloride Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0781-1487-01 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 27 | |
| 0781-1487-10 | Amitriptyline Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 27 | |
| 0781-1487-31 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 27 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-1487-01 | EA - Each | 0781-1487 | e12fef06-d014-4dcf-ad7d-631bfe4e61a8 | 1 | 2012-07-24 |
| 0781-1487-10 | EA - Each | 0781-1487 | ce06ad44-d664-47e6-aa26-1c5a38b4269c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | 471f3a17-baaa-cc35-e063-6294a90aed96 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | 085968 ANDA085968 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1523a2b4-f9d6-4d3c-a370-df579ed36911 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 085968 ANDA085968 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | d7bfeb47-2482-4217-b522-df4444499133 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 085968 ANDA085968 |
| Amitriptyline Hydrochloride | AMITRIPTYLINE HYDROCHLORIDE | Sandoz Inc | 705a2bae-031d-4218-82fe-4346542c0baa | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | 085968 ANDA085968 0781-1487 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856783 | amitriptyline HCl 10 MG Oral Tablet | PSN | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856762 | amitriptyline HCl 100 MG Oral Tablet | PSN | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856773 | amitriptyline HCl 150 MG Oral Tablet | PSN | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 1523a2b4-f9d6-4d3c-a370-df579ed36911 | 27 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856845 | amitriptyline HCl 50 MG Oral Tablet | PSN | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856853 | amitriptyline HCl 75 MG Oral Tablet | PSN | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856783 | amitriptyline hydrochloride 10 MG Oral Tablet | SCD | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856762 | amitriptyline hydrochloride 100 MG Oral Tablet | SCD | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856773 | amitriptyline hydrochloride 150 MG Oral Tablet | SCD | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 1523a2b4-f9d6-4d3c-a370-df579ed36911 | 27 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856845 | amitriptyline hydrochloride 50 MG Oral Tablet | SCD | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856853 | amitriptyline hydrochloride 75 MG Oral Tablet | SCD | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 41963d1c-8dd8-08ef-e054-00144ff8d46c | 9 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 41963d1c-8dd8-08ef-e054-00144ff8d46c | 9 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | d3eb7cb8-128d-4876-91ec-a56c0123ac90 | 5 |
| 856845 | amitriptyline HCl 50 MG Oral Tablet | PSN | d3eb7cb8-128d-4876-91ec-a56c0123ac90 | 5 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | d3eb7cb8-128d-4876-91ec-a56c0123ac90 | 5 |
| 856845 | amitriptyline hydrochloride 50 MG Oral Tablet | SCD | d3eb7cb8-128d-4876-91ec-a56c0123ac90 | 5 |
| 856783 | amitriptyline HCl 10 MG Oral Tablet | PSN | 94e984da-3b08-406f-8c10-e78844fca1ff | 4 |
| 856783 | amitriptyline HCl 10 MG Oral Tablet | PSN | eab6fbd5-50ca-4c52-bbe7-29d72d647daa | 4 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 255b0b8b-92b4-4d60-a312-9688014ad475 | 4 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 94e984da-3b08-406f-8c10-e78844fca1ff | 4 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | cbdca5ce-97c3-4be5-b193-ae07e2ac770d | 4 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | eab6fbd5-50ca-4c52-bbe7-29d72d647daa | 4 |
| 856845 | amitriptyline HCl 50 MG Oral Tablet | PSN | cbdca5ce-97c3-4be5-b193-ae07e2ac770d | 4 |
| 856845 | amitriptyline HCl 50 MG Oral Tablet | PSN | 94e984da-3b08-406f-8c10-e78844fca1ff | 4 |
| 856853 | amitriptyline HCl 75 MG Oral Tablet | PSN | eab6fbd5-50ca-4c52-bbe7-29d72d647daa | 4 |
| 856783 | amitriptyline hydrochloride 10 MG Oral Tablet | SCD | eab6fbd5-50ca-4c52-bbe7-29d72d647daa | 4 |
| 856783 | amitriptyline hydrochloride 10 MG Oral Tablet | SCD | 94e984da-3b08-406f-8c10-e78844fca1ff | 4 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 255b0b8b-92b4-4d60-a312-9688014ad475 | 4 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | cbdca5ce-97c3-4be5-b193-ae07e2ac770d | 4 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 94e984da-3b08-406f-8c10-e78844fca1ff | 4 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | eab6fbd5-50ca-4c52-bbe7-29d72d647daa | 4 |
| 856845 | amitriptyline hydrochloride 50 MG Oral Tablet | SCD | cbdca5ce-97c3-4be5-b193-ae07e2ac770d | 4 |
| 856845 | amitriptyline hydrochloride 50 MG Oral Tablet | SCD | 94e984da-3b08-406f-8c10-e78844fca1ff | 4 |
| 856853 | amitriptyline hydrochloride 75 MG Oral Tablet | SCD | eab6fbd5-50ca-4c52-bbe7-29d72d647daa | 4 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | f72a1419-0df4-4aaa-84cf-606a17cac493 | 3 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | f72a1419-0df4-4aaa-84cf-606a17cac493 | 3 |
| 856783 | amitriptyline HCl 10 MG Oral Tablet | PSN | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856762 | amitriptyline HCl 100 MG Oral Tablet | PSN | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856773 | amitriptyline HCl 150 MG Oral Tablet | PSN | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856845 | amitriptyline HCl 50 MG Oral Tablet | PSN | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856853 | amitriptyline HCl 75 MG Oral Tablet | PSN | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856783 | amitriptyline hydrochloride 10 MG Oral Tablet | SCD | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856762 | amitriptyline hydrochloride 100 MG Oral Tablet | SCD | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856773 | amitriptyline hydrochloride 150 MG Oral Tablet | SCD | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856845 | amitriptyline hydrochloride 50 MG Oral Tablet | SCD | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856853 | amitriptyline hydrochloride 75 MG Oral Tablet | SCD | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856783 | amitriptyline HCl 10 MG Oral Tablet | PSN | d441d278-2c54-4a22-83a3-4627d49aaae4 | 1 |
| 856762 | amitriptyline HCl 100 MG Oral Tablet | PSN | 460a2e4d-f1a2-4e08-b2da-f10bc63391db | 1 |
| 856762 | amitriptyline HCl 100 MG Oral Tablet | PSN | d441d278-2c54-4a22-83a3-4627d49aaae4 | 1 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 19678220-a53d-4275-a7fd-6d7b0fd686de | 1 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | d441d278-2c54-4a22-83a3-4627d49aaae4 | 1 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 460a2e4d-f1a2-4e08-b2da-f10bc63391db | 1 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 798b9002-9be1-48e6-978a-1b948584fa49 | 1 |
| 856845 | amitriptyline HCl 50 MG Oral Tablet | PSN | d441d278-2c54-4a22-83a3-4627d49aaae4 | 1 |
| 856845 | amitriptyline HCl 50 MG Oral Tablet | PSN | 460a2e4d-f1a2-4e08-b2da-f10bc63391db | 1 |
| 856853 | amitriptyline HCl 75 MG Oral Tablet | PSN | 460a2e4d-f1a2-4e08-b2da-f10bc63391db | 1 |
| 856783 | amitriptyline hydrochloride 10 MG Oral Tablet | SCD | d441d278-2c54-4a22-83a3-4627d49aaae4 | 1 |
| 856762 | amitriptyline hydrochloride 100 MG Oral Tablet | SCD | d441d278-2c54-4a22-83a3-4627d49aaae4 | 1 |
| 856762 | amitriptyline hydrochloride 100 MG Oral Tablet | SCD | 460a2e4d-f1a2-4e08-b2da-f10bc63391db | 1 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | d441d278-2c54-4a22-83a3-4627d49aaae4 | 1 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 460a2e4d-f1a2-4e08-b2da-f10bc63391db | 1 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 19678220-a53d-4275-a7fd-6d7b0fd686de | 1 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 798b9002-9be1-48e6-978a-1b948584fa49 | 1 |
| 856845 | amitriptyline hydrochloride 50 MG Oral Tablet | SCD | d441d278-2c54-4a22-83a3-4627d49aaae4 | 1 |
| 856845 | amitriptyline hydrochloride 50 MG Oral Tablet | SCD | 460a2e4d-f1a2-4e08-b2da-f10bc63391db | 1 |
| 856853 | amitriptyline hydrochloride 75 MG Oral Tablet | SCD | 460a2e4d-f1a2-4e08-b2da-f10bc63391db | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0781-1487-01 | 00781148701 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-1487-01) | 1977-11-21 | 0000-00-00 | No | No | Current |
| 0781-1487-10 | 00781148710 | 1000 TABLET, FILM COATED in 1 BOTTLE (0781-1487-10) | 1977-11-21 | 0000-00-00 | No | No | Current |
| 0781-1487-31 | 00781148731 | 30 in 1 BOTTLE | Historical |