AMITRIPTYLINE HYDROCHLORIDE

Product NDC
16729-172
11-digit product format
167290172
Labeler code
16729
Product ID
16729-172_ecb5bd74-ba7f-6546-e053-2a95a90a0a30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16729-172DDiscontinued by firm2026-08-11
excluded packagepackage16729-17216729-172-01DDiscontinued by firm2026-08-11
excluded packagepackage16729-17216729-172-10DDiscontinued by firm2026-08-11
excluded packagepackage16729-17216729-172-17DDiscontinued 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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16729-172-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16729-172-17d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16729-172-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16729-172-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16729-172-17f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16729-172-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16729-172-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16729-172-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16729-172-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16729-172-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16729-172-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16729-172-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16729-172-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16729-172-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16729-172-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16729-172-10557ba5c1ecfa…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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-172-01AMITRIPTYLINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1008
16729-172-10AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED308
16729-172-17AMITRIPTYLINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-172-01EA - Each16729-172b5b77dd4-3f4f-42cd-893b-61a91a2fb39212015-01-05
16729-172-17EA - Each16729-1726ca10192-a56a-4040-904d-d40d150ec7b312015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
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
Amitriptyline HydrochlorideACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Calcium SulfateINACTIVE INGREDIENTWAT0DDB505AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
Hydroxypropyl CelluloseINACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
TalcINACTIVE INGREDIENT7SEV7J4R1UAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-172AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]8Legacy NDC, 3 package rows20221106_1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd.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
856783amitriptyline HCl 10 MG Oral TabletPSN76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856762amitriptyline HCl 100 MG Oral TabletPSN76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856773amitriptyline HCl 150 MG Oral TabletPSN76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856834amitriptyline HCl 25 MG Oral TabletPSN76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856845amitriptyline HCl 50 MG Oral TabletPSN76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856853amitriptyline HCl 75 MG Oral TabletPSN76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856783amitriptyline hydrochloride 10 MG Oral TabletSCD76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856762amitriptyline hydrochloride 100 MG Oral TabletSCD76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856773amitriptyline hydrochloride 150 MG Oral TabletSCD76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856834amitriptyline hydrochloride 25 MG Oral TabletSCD76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856845amitriptyline hydrochloride 50 MG Oral TabletSCD76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856853amitriptyline hydrochloride 75 MG Oral TabletSCD76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856783amitriptyline HCl 10 MG Oral TabletPSN1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856762amitriptyline HCl 100 MG Oral TabletPSN1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856773amitriptyline HCl 150 MG Oral TabletPSN1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856834amitriptyline HCl 25 MG Oral TabletPSN1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856845amitriptyline HCl 50 MG Oral TabletPSN1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856853amitriptyline HCl 75 MG Oral TabletPSN1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856783amitriptyline hydrochloride 10 MG Oral TabletSCD1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856762amitriptyline hydrochloride 100 MG Oral TabletSCD1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856773amitriptyline hydrochloride 150 MG Oral TabletSCD1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856834amitriptyline hydrochloride 25 MG Oral TabletSCD1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856845amitriptyline hydrochloride 50 MG Oral TabletSCD1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856853amitriptyline hydrochloride 75 MG Oral TabletSCD1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856773amitriptyline HCl 150 MG Oral TabletPSN6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856834amitriptyline HCl 25 MG Oral TabletPSN0f4a2a75-0d9e-4c36-9b0a-2962c4114a274
856834amitriptyline HCl 25 MG Oral TabletPSN6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856834amitriptyline HCl 25 MG Oral TabletPSN6ac70bac-80e9-dc7b-e053-2a91aa0a61b54
856773amitriptyline hydrochloride 150 MG Oral TabletSCD6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856834amitriptyline hydrochloride 25 MG Oral TabletSCD0f4a2a75-0d9e-4c36-9b0a-2962c4114a274
856834amitriptyline hydrochloride 25 MG Oral TabletSCD6ac70bac-80e9-dc7b-e053-2a91aa0a61b54
856834amitriptyline hydrochloride 25 MG Oral TabletSCD6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856783amitriptyline HCl 10 MG Oral TabletPSN4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856834amitriptyline HCl 25 MG Oral TabletPSNc13566db-4db3-3ee1-e053-2a95a90a82ad2
856834amitriptyline HCl 25 MG Oral TabletPSNafffd3fb-47c7-0a4c-e053-2995a90af20c2
856834amitriptyline HCl 25 MG Oral TabletPSN8e6eeec4-73fa-fd12-e053-2995a90a4ea82
856834amitriptyline HCl 25 MG Oral TabletPSN1db11285-b9c7-5060-e054-00144ff8d46c2
856834amitriptyline HCl 25 MG Oral TabletPSN4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856783amitriptyline hydrochloride 10 MG Oral TabletSCD4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856834amitriptyline hydrochloride 25 MG Oral TabletSCD4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856834amitriptyline hydrochloride 25 MG Oral TabletSCD1db11285-b9c7-5060-e054-00144ff8d46c2
856834amitriptyline hydrochloride 25 MG Oral TabletSCD8e6eeec4-73fa-fd12-e053-2995a90a4ea82
856834amitriptyline hydrochloride 25 MG Oral TabletSCDafffd3fb-47c7-0a4c-e053-2995a90af20c2
856834amitriptyline hydrochloride 25 MG Oral TabletSCDc13566db-4db3-3ee1-e053-2a95a90a82ad2
856762amitriptyline HCl 100 MG Oral TabletPSN59774c8a-de96-53a6-e053-2991aa0a709f1
856834amitriptyline HCl 25 MG Oral TabletPSN59774c8a-de96-53a6-e053-2991aa0a709f1
856834amitriptyline HCl 25 MG Oral TabletPSNb29a161a-be0c-40a8-b68e-0071f58fcad01
856845amitriptyline HCl 50 MG Oral TabletPSN59774c8a-de96-53a6-e053-2991aa0a709f1
856762amitriptyline hydrochloride 100 MG Oral TabletSCD59774c8a-de96-53a6-e053-2991aa0a709f1
856834amitriptyline hydrochloride 25 MG Oral TabletSCD59774c8a-de96-53a6-e053-2991aa0a709f1
856834amitriptyline hydrochloride 25 MG Oral TabletSCDb29a161a-be0c-40a8-b68e-0071f58fcad01
856845amitriptyline hydrochloride 50 MG Oral TabletSCD59774c8a-de96-53a6-e053-2991aa0a709f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-172-0116729017201100 TABLET, FILM COATED in 1 BOTTLE (16729-172-01) 2014-12-050000-00-00NoNoCurrent
16729-172-101672901721030 in 1 BOTTLEHistorical
16729-172-17167290172171000 TABLET, FILM COATED in 1 BOTTLE (16729-172-17) 2014-12-050000-00-00NoNoCurrent