Amitriptyline Hydrochloride

Product NDC
50090-5754
Requested package NDC
50090-5754-0
11-digit product format
500905754
Labeler code
50090
Product ID
50090-5754_4559c206-8ef6-408a-b646-34cdd2dacf1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA085968
Marketing category
ANDA
Marketing start
1977-11-29
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-575450090-5754-0IInactivated by FDA2026-08-10

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A085968-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 1982
A085968-002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 1982
A085968-003AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 1982
A085968-004AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 1982
A085968-005AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 1982
A085968-006AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A085968-001AB
A085968-002AB
A085968-003AB
A085968-004AB
A085968-005AB
A085968-006AB

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 6 · 226 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-005AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-006AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-005AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-006AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-005AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-006AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-005AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-006AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-005AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-006AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-005AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-006AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 226 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A085968-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085968-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-004AB12680178bc6a6…

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
50090-5754-02023-01-30C16284748780-1f386c649-b6c2-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5754-0Amitriptyline Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED11
50090-5754-0Amitriptyline Hydrochloride33 in 1 CARTONTABLET, FILM COATED331

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5754AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20211007_5fb87299-fca3-4303-8931-d9dfcaf4aa06.zip

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.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLC471f3a17-baaa-cc35-e063-6294a90aed962025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085968
application number: ANDA085968
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1523a2b4-f9d6-4d3c-a370-df579ed369112025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085968
application number: ANDA085968
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d7bfeb47-2482-4217-b522-df44444991332025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085968
application number: ANDA085968
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESandoz Inc705a2bae-031d-4218-82fe-4346542c0baa2025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085968
application number: ANDA085968

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN5fb87299-fca3-4303-8931-d9dfcaf4aa061
856845amitriptyline hydrochloride 50 MG Oral TabletSCD5fb87299-fca3-4303-8931-d9dfcaf4aa061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5754-05009057540033 BLISTER PACK in 1 CARTON (50090-5754-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK33 blister pack2021-09-300000-00-00NoNoCurrent