FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
63187-156
Requested package NDC
63187-156-60
11-digit product format
631870156
Labeler code
63187
Product ID
63187-156_8de781ff-8ad8-48c4-aa07-4714a2be1854
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040218
Marketing category
ANDA
Marketing start
1997-09-11
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 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 packagepackage63187-15663187-156-60DDiscontinued by firm2026-09-14

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-15663187-156-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-15663187-156-60DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040218-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11
A040218-002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11
A040218-003AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11
A040218-004AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11
A040218-005AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11
A040218-006AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-1184e616aacf4f…
2026-08-18 06:07:402026-07A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040218-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040218-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040218-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040218-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-006AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040218-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-005AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-006AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040218-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040218-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040218-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040218-004AB187673890dc5c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63187-156-602019-12-04C16284748780-19855e2a2-4d88-60a7-e053-dbdaa90a05bdAMITRIPTYLINE HYDROCHLORIDE TABLETS, USP Rx only
63187-156-602019-11-27C16284748780-19855e2a2-4d88-60a7-e053-dbdaa90a05bdAMITRIPTYLINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-156AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2Legacy NDC20191205_da7c5db6-a950-401c-90ed-c2ca433b2bb3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-156-606318701566060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-156-60) 2014-09-010000-00-00NoNoCurrent