AMITRIPTYLINE HYDROCHLORIDE

Product NDC
72189-309
Requested package NDC
72189-309-30
11-digit product format
721890309
Labeler code
72189
Product ID
72189-309_d44efada-eee3-747e-e053-2995a90af561
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRx
Application
ANDA202446
Marketing category
ANDA
Marketing start
2021-12-29
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
75 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 packagepackage72189-30972189-309-30IInactivated by FDA2026-08-07

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 · 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
A202446-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-04
A202446-002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2014-06-04
A202446-003AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2014-06-04
A202446-004AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2014-06-04
A202446-005AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2014-06-04
A202446-006AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2014-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202446-001AB
A202446-002AB
A202446-003AB
A202446-004AB
A202446-005AB
A202446-006AB

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 UTC2026-02A202446-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202446-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2014-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202446-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2014-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202446-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2014-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202446-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2014-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202446-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2014-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202446-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202446-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2014-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202446-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2014-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202446-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2014-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202446-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2014-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202446-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2014-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202446-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202446-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2014-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202446-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2014-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202446-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2014-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202446-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2014-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202446-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2014-06-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202446-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202446-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2014-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202446-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2014-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202446-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2014-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202446-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2014-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202446-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2014-06-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202446-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202446-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2014-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202446-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2014-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202446-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2014-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202446-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2014-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202446-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2014-06-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202446-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202446-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2014-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202446-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2014-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202446-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2014-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202446-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2014-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202446-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2014-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202446-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202446-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2014-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202446-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2014-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202446-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2014-06-042680178bc6a6…

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 UTC2026-02A202446-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202446-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202446-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202446-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202446-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202446-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202446-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202446-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202446-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202446-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202446-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202446-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202446-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202446-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202446-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202446-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202446-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202446-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202446-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202446-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202446-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202446-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202446-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202446-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202446-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202446-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202446-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202446-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202446-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202446-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202446-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202446-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202446-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202446-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202446-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202446-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202446-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202446-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202446-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202446-004AB12680178bc6a6…

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
72189-309-302025-01-30C16284748780-12cef2736-a872-d83d-e063-dadaa90ab31fAMITRIPTYLINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-309-30AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-309-30EA - Each72189-309c15d2304-f408-440e-94d8-e1d6a270234312022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-309AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECTRX]1Legacy NDC, 1 package rows20211230_d44efada-eee2-747e-e053-2995a90af561.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLCe3afe026-7072-0a7d-e053-2995a90a52d42026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202446
application number: ANDA202446
Amitriptyline HCLAMITRIPTYLINE HCLAdvanced Rx Pharmacy of Tennessee, LLCca66c2fc-6724-f4cd-e053-2995a90a42cf2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202446
application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack76d3f4fd-4603-4cfc-94ab-2e62c0bdae752024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202446
application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.58ff9a82-5de6-a1b0-e053-2991aa0a84ba2024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202446
application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.5a5a4040-5395-54ac-e053-2991aa0aa4ab2024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202446
application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions9440dd10-2f0d-42a7-a037-3ab8729708f62023-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202446
application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEProficient Rx LPdf5aee40-ffa9-4cf3-ab5f-30253f43092b2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202446
application number: ANDA202446

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856853amitriptyline HCl 75 MG Oral TabletPSNd44efada-eee2-747e-e053-2995a90af5611
856853amitriptyline hydrochloride 75 MG Oral TabletSCDd44efada-eee2-747e-e053-2995a90af5611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-309-307218903093030 TABLET, FILM COATED in 1 BOTTLE (72189-309-30) 2021-12-290000-00-00NoNoCurrent