AMITRIPTYLINE HYDROCHLORIDE

Product NDC
63187-408
Requested package NDC
63187-408-15
11-digit product format
631870408
Labeler code
63187
Product ID
63187-408_692f0996-d431-4fcd-b03b-f1413f00d958
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202446
Marketing category
ANDA
Marketing start
2014-12-05
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
2023-12-31
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 packagepackage63187-40863187-408-15DDiscontinued by firm2026-10-05

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
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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202446-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-0484e616aacf4f…
2026-09-14 22:38:342026-08A202446-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2014-06-0484e616aacf4f…
2026-09-14 22:38:342026-08A202446-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2014-06-0484e616aacf4f…
2026-09-14 22:38:342026-08A202446-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2014-06-0484e616aacf4f…
2026-09-14 22:38:342026-08A202446-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2014-06-0484e616aacf4f…
2026-09-14 22:38:342026-08A202446-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2014-06-0484e616aacf4f…
2026-08-18 06:07:402026-07A202446-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202446-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2014-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202446-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2014-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202446-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2014-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202446-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2014-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202446-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2014-06-04caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202446-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202446-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202446-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A202446-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A202446-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A202446-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A202446-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202446-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202446-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202446-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202446-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202446-006AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-408-14EA - Each63187-4087255f86d-7116-4c07-9835-4dea7f99dd1912022-06-06
63187-408-15EA - Each63187-408fd7f81c6-55cd-4013-9979-15f9911e00e912017-08-11
63187-408-30EA - Each63187-408fe0e4289-eaf2-41e2-9b5a-c55fe33e18dc12022-03-09
63187-408-60EA - Each63187-408f6dcceb5-9e0b-4a9a-b81b-44c55d3a4f0812016-09-02
63187-408-90EA - Each63187-4080319b41f-92be-48f8-a2da-139f293ebac612019-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2
TALCINACTIVE INGREDIENT7SEV7J4R1UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-408AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]8Legacy NDC20220930_eb79d126-c35c-4536-b81d-ad370109c7fe.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-408-156318704081515 TABLET, FILM COATED in 1 BOTTLE (63187-408-15) 2017-06-010000-00-00NoNoCurrent