FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
43353-163
Requested package NDC
43353-163-60
11-digit product format
433530163
Labeler code
43353
Product ID
43353-163_c52cd2ff-b891-4423-b147-143dfbe78a11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA085966
Marketing category
ANDA
Marketing start
1977-11-21
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
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 packagepackage43353-16343353-163-60IInactivated 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 · 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.

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 UTC2019-12A085966-001AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRS, Approved before 198274a2ff9319b5…
2019-12-14 00:12 UTC2019-12A085966-001AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A085966-001AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A085966-001AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRS, Approved before 1982ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A085966-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A085966-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A085966-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085966-001AB1ea99ee380514…

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
43353-163-302023-01-30C16284748780-1f386c649-ca6c-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP
43353-163-532023-01-30C16284748780-1f386c649-ca6c-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP
43353-163-602023-01-30C16284748780-1f386c649-ca6c-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-163-30Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
43353-163-53Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
43353-163-60Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-163-53EA - Each43353-1633d24534b-a841-4489-9b96-fc7a371edf8412016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-163AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 3 package rows20191219_cbdca5ce-97c3-4be5-b193-ae07e2ac770d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSNcbdca5ce-97c3-4be5-b193-ae07e2ac770d4
856845amitriptyline HCl 50 MG Oral TabletPSNcbdca5ce-97c3-4be5-b193-ae07e2ac770d4
856834amitriptyline hydrochloride 25 MG Oral TabletSCDcbdca5ce-97c3-4be5-b193-ae07e2ac770d4
856845amitriptyline hydrochloride 50 MG Oral TabletSCDcbdca5ce-97c3-4be5-b193-ae07e2ac770d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-163-604335301636090 TABLET, FILM COATED in 1 BOTTLE (43353-163-60) 2016-04-120000-00-00NoNoCurrent