Amitriptyline Hydrochloride

Product NDC
43063-336
11-digit product format
430630336
Labeler code
43063
Product ID
43063-336_7d3ee8e2-0a85-e419-e053-2991aa0a5d70
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
75 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43063-336DDiscontinued by firm2026-08-11
excluded packagepackage43063-33643063-336-30DDiscontinued by firm2026-08-11
excluded packagepackage43063-33643063-336-60DDiscontinued 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 1 · 36 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 packagepackage43063-336-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-336-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-336-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-336-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-336-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-336-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-336-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-336-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-336-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-336-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-336-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-336-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-336-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-336-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43063-336-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43063-336-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43063-336-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43063-336-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43063-336-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43063-336-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43063-336-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43063-336-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43063-336-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43063-336-60557ba5c1ecfa…9c80585c8c6e…

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
43063-336-30EA - Each43063-336fdf65806-3008-4db8-abe0-d3e19ddb842312012-07-24
43063-336-60EA - Each43063-33668e78e54-1cc9-498c-82eb-3129d411bd1812012-07-24