Amitriptyline Hydrochloride

Product NDC
0781-1490
11-digit product format
007811490
Labeler code
0781
Product ID
0781-1490_9df45420-7268-454e-9624-8da48c97b7db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA085968
Marketing category
ANDA
Marketing start
1977-11-21
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
100 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0781-14900781-1490-10DDiscontinued by firm2026-08-07
excluded packagepackage0781-14900781-1490-31DDiscontinued by firm2026-08-07

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050781-1490-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050781-1490-31d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260781-1490-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260781-1490-31f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310781-1490-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310781-1490-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280781-1490-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280781-1490-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210781-1490-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210781-1490-31cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100781-1490-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100781-1490-31cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310781-1490-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310781-1490-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200781-1490-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200781-1490-31ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100781-1490-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100781-1490-310efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080781-1490-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080781-1490-31ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030781-1490-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030781-1490-31367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090781-1490-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090781-1490-31557ba5c1ecfa…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
A085968-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 1982
A085968-002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 1982
A085968-003AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 1982
A085968-004AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 1982
A085968-005AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 1982
A085968-006AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A085968-001AB
A085968-002AB
A085968-003AB
A085968-004AB
A085968-005AB
A085968-006AB

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 6 · 226 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-005AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-006AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-005AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-006AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-005AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-006AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-005AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-006AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-005AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-006AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-005AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-006AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-003AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-004AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 226 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A085968-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085968-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085968-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085968-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085968-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085968-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085968-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085968-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085968-004AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE100 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856762Internal RxNorm lookup
856773Internal RxNorm lookup
856783Internal RxNorm lookup
856834Internal RxNorm lookup
856845Internal RxNorm lookup
856853Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
705a2bae-031d-4218-82fe-4346542c0baaAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-1490-01Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10027
0781-1490-10Amitriptyline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100027
0781-1490-31Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1490-01EA - Each0781-14906b321dab-1b23-4dfc-bf3d-2293246aa35a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1490AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]26Current NDC, Legacy NDC, 3 package rows20240322_705a2bae-031d-4218-82fe-4346542c0baa.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLC471f3a17-baaa-cc35-e063-6294a90aed962025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085968
application number: ANDA085968
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1523a2b4-f9d6-4d3c-a370-df579ed369112025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085968
application number: ANDA085968
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d7bfeb47-2482-4217-b522-df44444991332025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085968
application number: ANDA085968
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESandoz Inc705a2bae-031d-4218-82fe-4346542c0baa2025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085968
application number: ANDA085968
ndc (product): 0781-1490

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN705a2bae-031d-4218-82fe-4346542c0baa27
856762amitriptyline HCl 100 MG Oral TabletPSN705a2bae-031d-4218-82fe-4346542c0baa27
856773amitriptyline HCl 150 MG Oral TabletPSN705a2bae-031d-4218-82fe-4346542c0baa27
856834amitriptyline HCl 25 MG Oral TabletPSN705a2bae-031d-4218-82fe-4346542c0baa27
856845amitriptyline HCl 50 MG Oral TabletPSN705a2bae-031d-4218-82fe-4346542c0baa27
856853amitriptyline HCl 75 MG Oral TabletPSN705a2bae-031d-4218-82fe-4346542c0baa27
856783amitriptyline hydrochloride 10 MG Oral TabletSCD705a2bae-031d-4218-82fe-4346542c0baa27
856762amitriptyline hydrochloride 100 MG Oral TabletSCD705a2bae-031d-4218-82fe-4346542c0baa27
856773amitriptyline hydrochloride 150 MG Oral TabletSCD705a2bae-031d-4218-82fe-4346542c0baa27
856834amitriptyline hydrochloride 25 MG Oral TabletSCD705a2bae-031d-4218-82fe-4346542c0baa27
856845amitriptyline hydrochloride 50 MG Oral TabletSCD705a2bae-031d-4218-82fe-4346542c0baa27
856853amitriptyline hydrochloride 75 MG Oral TabletSCD705a2bae-031d-4218-82fe-4346542c0baa27
856783amitriptyline HCl 10 MG Oral TabletPSN8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856762amitriptyline HCl 100 MG Oral TabletPSN8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856773amitriptyline HCl 150 MG Oral TabletPSN8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856834amitriptyline HCl 25 MG Oral TabletPSN8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856845amitriptyline HCl 50 MG Oral TabletPSN8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856853amitriptyline HCl 75 MG Oral TabletPSN8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856783amitriptyline hydrochloride 10 MG Oral TabletSCD8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856762amitriptyline hydrochloride 100 MG Oral TabletSCD8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856773amitriptyline hydrochloride 150 MG Oral TabletSCD8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856834amitriptyline hydrochloride 25 MG Oral TabletSCD8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856845amitriptyline hydrochloride 50 MG Oral TabletSCD8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856853amitriptyline hydrochloride 75 MG Oral TabletSCD8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856783amitriptyline HCl 10 MG Oral TabletPSNd441d278-2c54-4a22-83a3-4627d49aaae41
856762amitriptyline HCl 100 MG Oral TabletPSN460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856762amitriptyline HCl 100 MG Oral TabletPSNd441d278-2c54-4a22-83a3-4627d49aaae41
856834amitriptyline HCl 25 MG Oral TabletPSNd441d278-2c54-4a22-83a3-4627d49aaae41
856834amitriptyline HCl 25 MG Oral TabletPSN460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856845amitriptyline HCl 50 MG Oral TabletPSN460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856845amitriptyline HCl 50 MG Oral TabletPSNd441d278-2c54-4a22-83a3-4627d49aaae41
856853amitriptyline HCl 75 MG Oral TabletPSN460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856783amitriptyline hydrochloride 10 MG Oral TabletSCDd441d278-2c54-4a22-83a3-4627d49aaae41
856762amitriptyline hydrochloride 100 MG Oral TabletSCDd441d278-2c54-4a22-83a3-4627d49aaae41
856762amitriptyline hydrochloride 100 MG Oral TabletSCD460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856834amitriptyline hydrochloride 25 MG Oral TabletSCD460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856834amitriptyline hydrochloride 25 MG Oral TabletSCDd441d278-2c54-4a22-83a3-4627d49aaae41
856845amitriptyline hydrochloride 50 MG Oral TabletSCDd441d278-2c54-4a22-83a3-4627d49aaae41
856845amitriptyline hydrochloride 50 MG Oral TabletSCD460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856853amitriptyline hydrochloride 75 MG Oral TabletSCD460a2e4d-f1a2-4e08-b2da-f10bc63391db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-1490-0100781149001100 TABLET, FILM COATED in 1 BOTTLE (0781-1490-01) 1977-11-210000-00-00NoNoCurrent
0781-1490-10007811490101000 in 1 BOTTLEHistorical
0781-1490-310078114903130 in 1 BOTTLEHistorical