Amitriptyline Hydrochloride

Product NDC
67296-1509
11-digit product format
672961509
Labeler code
67296
Product ID
67296-1509_d61b948d-1f1f-7c00-e053-2a95a90a8802
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040218
Marketing category
ANDA
Marketing start
1997-09-11
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1509IInactivated by FDA2026-08-17
excluded packagepackage67296-150967296-1509-3IInactivated by FDA2026-08-17

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-1509-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-1509-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-1509-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-1509-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-1509-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-1509-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-1509-3IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-1509-3IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-1509-3IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-1509-3IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-1509-3IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1509-3IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1509-3IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1509-3IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1509-3IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-1509-3EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11caaa826d4ba7…
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…

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5006e90-7f2e-4341-bcdb-f83027a8fc39Product name620240611
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1509-32024-01-30C16284748780-11030e365-10fc-111a-e063-dadaa90a10e250d7ed6a-ef44-593d-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1509-3Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1509AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20220122_50d7ed6a-ef44-593d-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN50d7ed6a-ef44-593d-e054-00144ff8d46c4
856783amitriptyline hydrochloride 10 MG Oral TabletSCD50d7ed6a-ef44-593d-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1509-36729615090330 TABLET, FILM COATED in 1 BOTTLE (67296-1509-3) 1997-09-110000-00-00NoNoCurrent