Amitriptyline Hydrochloride

Product NDC
55289-730
11-digit product format
552890730
Labeler code
55289
Product ID
55289-730_77803903-839e-8532-e053-2a91aa0a3078
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040218
Marketing category
ANDA
Marketing start
1997-09-11
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55289-730DDiscontinued by firm2026-08-11
excluded packagepackage55289-73055289-730-01DDiscontinued by firm2026-08-11
excluded packagepackage55289-73055289-730-12DDiscontinued by firm2026-08-11
excluded packagepackage55289-73055289-730-25DDiscontinued by firm2026-08-11
excluded packagepackage55289-73055289-730-30DDiscontinued by firm2026-08-11
excluded packagepackage55289-73055289-730-60DDiscontinued by firm2026-08-11
excluded packagepackage55289-73055289-730-90DDiscontinued by firm2026-08-11

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.

Historic NDC status page 1 of 2 · 84 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-730-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-730-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-730-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-730-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-730-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-730-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-730-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-730-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-730-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-730-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-730-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-730-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-730-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-730-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-730-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-730-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-730-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-730-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-730-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-730-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-730-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-730-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-730-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-730-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-730-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-730-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-730-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-730-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-730-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-730-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-730-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-730-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-730-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-730-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-730-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-730-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55289-730-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55289-730-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55289-730-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55289-730-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55289-730-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55289-730-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55289-730-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55289-730-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55289-730-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55289-730-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55289-730-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55289-730-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55289-730-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55289-730-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55289-730-010efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040218-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11
A040218-002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11
A040218-003AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11
A040218-004AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11
A040218-005AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11
A040218-006AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-112680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040218-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040218-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040218-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040218-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-006AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040218-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-005AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-006AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040218-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040218-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040218-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040218-004AB187673890dc5c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-730-01EA - Each55289-7301ae5622b-9f74-4674-94e9-c93916a93f8c12012-07-24
55289-730-12EA - Each55289-73032bd5a8a-8ad3-4cc3-a3fa-4e5da3b6651e12012-07-24
55289-730-25EA - Each55289-73027a5da74-865a-41af-bc96-f841da37a97a12012-07-24
55289-730-30EA - Each55289-7308113fab7-c44f-42d9-afc1-3be3ee22a09d12012-07-24
55289-730-60EA - Each55289-7307771e1a3-61f3-402e-a86f-9f437c43177f12012-07-24
55289-730-90EA - Each55289-730d156b901-d3fc-4890-a978-7dbbe757fd5a12012-07-24