FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
45865-648
Requested package NDC
45865-648-30
11-digit product format
458650648
Labeler code
45865
Product ID
45865-648_9ab35d14-5adc-51a8-e053-2a95a90ada8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA085969
Marketing category
ANDA
Marketing start
1977-11-21
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
2020-12-31
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 packagepackage45865-64845865-648-30IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog.

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A085969-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABApproved before 198274a2ff9319b5…
2019-12-14 00:12 UTC2019-12A085969-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A085969-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A085969-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABApproved before 1982ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A085969-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A085969-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A085969-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085969-001AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
45865-648-302025-01-30C16284748780-12cef2736-96a8-d83d-e063-dadaa90ab31fAmitriptyline Hydrochloride Tablets, USP
45865-648-602025-01-30C16284748780-12cef2736-96a8-d83d-e063-dadaa90ab31fAmitriptyline Hydrochloride Tablets, USP
45865-648-902025-01-30C16284748780-12cef2736-96a8-d83d-e063-dadaa90ab31fAmitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-648-30Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
45865-648-60Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
45865-648-90Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-648AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 3 package rows20191228_7205c0e2-d7f9-3451-e053-2a95a90a69b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN7205c0e2-d7f9-3451-e053-2a95a90a69b02
856783amitriptyline hydrochloride 10 MG Oral TabletSCD7205c0e2-d7f9-3451-e053-2a95a90a69b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-648-304586506483030 TABLET, FILM COATED in 1 BOTTLE (45865-648-30) 2018-01-010000-00-00NoNoCurrent