FDA.reportPublic FDA data

AMITRIPTYLINE HYDROCHLORIDE

Product NDC
63629-1369
Requested package NDC
63629-1369-9
11-digit product format
636291369
Labeler code
63629
Product ID
63629-1369_8d720a85-1135-4a34-9e56-381b39c28fb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2021-12-31
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 packagepackage63629-136963629-1369-9DDiscontinued by firm2026-10-15

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, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05IInactivated by FDA110d247fa046…a55b01930146…

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-1369-02021-01-06Amitriptyline Hydrochloride Tablets, USP
63629-1369-12021-01-06Amitriptyline Hydrochloride Tablets, USP
63629-1369-22021-01-06Amitriptyline Hydrochloride Tablets, USP
63629-1369-32021-01-06Amitriptyline Hydrochloride Tablets, USP
63629-1369-42021-01-06Amitriptyline Hydrochloride Tablets, USP
63629-1369-52021-01-06Amitriptyline Hydrochloride Tablets, USP
63629-1369-62021-01-06Amitriptyline Hydrochloride Tablets, USP
63629-1369-72021-01-06Amitriptyline Hydrochloride Tablets, USP
63629-1369-82021-01-06Amitriptyline Hydrochloride Tablets, USP
63629-1369-92021-01-06Amitriptyline Hydrochloride Tablets, USP
63629-1369-02019-11-27Amitriptyline Hydrochloride Tablets, USP
63629-1369-12019-11-27Amitriptyline Hydrochloride Tablets, USP
63629-1369-22019-11-27Amitriptyline Hydrochloride Tablets, USP
63629-1369-32019-11-27Amitriptyline Hydrochloride Tablets, USP
63629-1369-42019-11-27Amitriptyline Hydrochloride Tablets, USP
63629-1369-52019-11-27Amitriptyline Hydrochloride Tablets, USP
63629-1369-62019-11-27Amitriptyline Hydrochloride Tablets, USP
63629-1369-72019-11-27Amitriptyline Hydrochloride Tablets, USP
63629-1369-82019-11-27Amitriptyline Hydrochloride Tablets, USP
63629-1369-92019-11-27Amitriptyline Hydrochloride Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1369-1EA - Each63629-1369f8ea5358-a9d2-4cc2-9a9f-8ab6c54063d812012-07-24
63629-1369-2EA - Each63629-1369ca6602e9-c962-474f-8aa5-7f632c3d358812012-07-24
63629-1369-3EA - Each63629-13691b6b8598-50a3-4314-bec0-f164d287a10b12012-07-24
63629-1369-4EA - Each63629-1369890b5668-3049-40b6-ab47-495dd34cd5ba12012-07-24
63629-1369-5EA - Each63629-1369c63892cc-0903-4de1-b24f-0d0aa3da171712012-07-24
63629-1369-6EA - Each63629-1369e15ff982-5476-436f-9006-382ebf7adb1f12012-07-24
63629-1369-7EA - Each63629-1369f7abe0eb-a853-44fc-ac97-ccb55b5a537d12012-07-24
63629-1369-8EA - Each63629-1369a36c363e-426a-49d3-8cbe-a4a8de9c6b9612012-07-24
63629-1369-9EA - Each63629-136930e674bd-aa12-4e4e-964e-f54f881e2c4d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1369-96362913690956 TABLET, FILM COATED in 1 BOTTLE (63629-1369-9) 1977-11-210000-00-00NoNoCurrent