FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
71335-1256
Requested package NDC
71335-1256-3
11-digit product format
713351256
Labeler code
71335
Product ID
71335-1256_0f092778-43f5-15d0-e063-6394a90a1215
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089399
Marketing category
ANDA
Marketing start
1987-07-14
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage71335-125671335-1256-3DDiscontinued by firm2026-08-11

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 · 12 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…

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
A089399-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB1987-07-14
A089399-002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB1987-07-14
A089399-003AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB1987-07-14
A089399-004AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB1987-07-14
A089399-005AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB1987-07-14
A089399-006AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB1987-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089399-001AB
A089399-002AB
A089399-003AB
A089399-004AB
A089399-005AB
A089399-006AB

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A089399-001AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB1987-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089399-002AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB1987-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089399-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB1987-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089399-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB1987-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089399-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB1987-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089399-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB1987-07-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089399-001AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB1987-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089399-002AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB1987-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089399-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB1987-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089399-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB1987-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089399-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB1987-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089399-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB1987-07-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A089399-001AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB1987-07-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089399-002AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB1987-07-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089399-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB1987-07-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089399-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB1987-07-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089399-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB1987-07-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089399-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB1987-07-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089399-001AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB1987-07-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089399-002AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB1987-07-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089399-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB1987-07-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089399-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB1987-07-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089399-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB1987-07-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089399-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB1987-07-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089399-001AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB1987-07-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089399-002AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB1987-07-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089399-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB1987-07-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089399-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB1987-07-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089399-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB1987-07-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089399-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB1987-07-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089399-001AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB1987-07-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089399-002AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB1987-07-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089399-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB1987-07-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089399-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB1987-07-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089399-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB1987-07-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089399-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB1987-07-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089399-001AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB1987-07-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089399-002AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB1987-07-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089399-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB1987-07-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089399-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB1987-07-142680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A089399-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089399-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089399-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089399-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089399-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089399-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089399-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089399-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089399-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089399-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089399-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089399-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089399-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089399-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089399-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089399-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089399-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089399-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089399-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089399-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089399-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089399-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089399-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089399-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089399-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089399-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089399-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089399-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089399-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089399-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089399-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089399-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089399-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089399-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089399-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089399-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089399-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089399-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089399-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089399-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Amitriptyline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
26LUD4JO9KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856845Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dcdeb999-412e-475f-a21d-2e0ac42d136eAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1256-1Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100101
71335-1256-2Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30101
71335-1256-3Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60101
71335-1256-4Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90101
71335-1256-5Amitriptyline Hydrochloride20 in 1 BOTTLETABLET, FILM COATED20101
71335-1256-6Amitriptyline Hydrochloride28 in 1 BOTTLETABLET, FILM COATED28101
71335-1256-7Amitriptyline Hydrochloride56 in 1 BOTTLETABLET, FILM COATED56101
71335-1256-8Amitriptyline Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1256-2EA - Each71335-12568096fbd9-130d-4530-bc50-b3c95a31301e12019-09-05
71335-1256-3EA - Each71335-12564c956f9f-bbd3-4820-8a6c-09a7505e846212019-09-05
71335-1256-4EA - Each71335-125666163a15-f786-43af-8a69-15316eab0bc912019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1256AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 8 package rows20240117_dcdeb999-412e-475f-a21d-2e0ac42d136e.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEGolden State Medical Supply, Inc.04e1c5f8-de7e-8ce7-e063-6394a90acc572025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089399
application number: ANDA089399
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.4e520c63-1cf6-40f6-a51c-3f9b0e1813422025-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089399
application number: ANDA089399
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack541ba74a-babb-4731-a5ef-fe7c18992c0b2024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089399
application number: ANDA089399
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackdcdeb999-412e-475f-a21d-2e0ac42d136e2024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089399
application number: ANDA089399
ndc (package): 71335-1256-3
ndc (product): 71335-1256
ndc11 (package): 71335125603
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC25832051-837b-4682-8548-5ab9a1b7cdac2023-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089399
application number: ANDA089399
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4e0f3b15-3621-48a1-9f2b-b0a3739203602023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089399
application number: ANDA089399

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSNdcdeb999-412e-475f-a21d-2e0ac42d136e101
856845amitriptyline hydrochloride 50 MG Oral TabletSCDdcdeb999-412e-475f-a21d-2e0ac42d136e101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1256-37133512560360 TABLET, FILM COATED in 1 BOTTLE (71335-1256-3) 2022-02-090000-00-00NoNoCurrent