FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
57664-688
11-digit product format
576640688
Labeler code
57664
Product ID
57664-688_326a1cd7-1376-8b5e-e063-6294a90a80aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA089399
Marketing category
ANDA
Marketing start
1987-07-14
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856762, 856773, 856783, 856834, 856845, 856853

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
57664-688-18Amitriptyline Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10009
57664-688-88Amitriptyline Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-688-18EA - Each57664-6883a8d3916-025d-48fe-aeed-38f63088d51212018-07-03
57664-688-88EA - Each57664-6880c4d8c87-02d0-4dc3-8e3c-dddb02e6b51f12018-07-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amitriptyline HydrochlorideACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
AmitriptylineACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
D&C Red No. 27INACTIVE INGREDIENT2LRS185U6KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
D&C Red No. 30INACTIVE INGREDIENT2S42T2808BAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
D&C Red No. 7INACTIVE INGREDIENTECW0LZ41X8AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
hydroxypropyl cellulose (type h)INACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-688AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC, 2 package rows20250412_4e520c63-1cf6-40f6-a51c-3f9b0e181342.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN4e520c63-1cf6-40f6-a51c-3f9b0e1813429
856762amitriptyline HCl 100 MG Oral TabletPSN4e520c63-1cf6-40f6-a51c-3f9b0e1813429
856773amitriptyline HCl 150 MG Oral TabletPSN4e520c63-1cf6-40f6-a51c-3f9b0e1813429
856834amitriptyline HCl 25 MG Oral TabletPSN4e520c63-1cf6-40f6-a51c-3f9b0e1813429
856845amitriptyline HCl 50 MG Oral TabletPSN4e520c63-1cf6-40f6-a51c-3f9b0e1813429
856853amitriptyline HCl 75 MG Oral TabletPSN4e520c63-1cf6-40f6-a51c-3f9b0e1813429
856783amitriptyline hydrochloride 10 MG Oral TabletSCD4e520c63-1cf6-40f6-a51c-3f9b0e1813429
856762amitriptyline hydrochloride 100 MG Oral TabletSCD4e520c63-1cf6-40f6-a51c-3f9b0e1813429
856773amitriptyline hydrochloride 150 MG Oral TabletSCD4e520c63-1cf6-40f6-a51c-3f9b0e1813429
856834amitriptyline hydrochloride 25 MG Oral TabletSCD4e520c63-1cf6-40f6-a51c-3f9b0e1813429
856845amitriptyline hydrochloride 50 MG Oral TabletSCD4e520c63-1cf6-40f6-a51c-3f9b0e1813429
856853amitriptyline hydrochloride 75 MG Oral TabletSCD4e520c63-1cf6-40f6-a51c-3f9b0e1813429
856783amitriptyline HCl 10 MG Oral TabletPSN4e0f3b15-3621-48a1-9f2b-b0a3739203607
856834amitriptyline HCl 25 MG Oral TabletPSN4e0f3b15-3621-48a1-9f2b-b0a3739203607
856845amitriptyline HCl 50 MG Oral TabletPSN4e0f3b15-3621-48a1-9f2b-b0a3739203607
856783amitriptyline hydrochloride 10 MG Oral TabletSCD4e0f3b15-3621-48a1-9f2b-b0a3739203607
856834amitriptyline hydrochloride 25 MG Oral TabletSCD4e0f3b15-3621-48a1-9f2b-b0a3739203607
856845amitriptyline hydrochloride 50 MG Oral TabletSCD4e0f3b15-3621-48a1-9f2b-b0a3739203607
856783amitriptyline HCl 10 MG Oral TabletPSN04e1c5f8-de7e-8ce7-e063-6394a90acc574
856762amitriptyline HCl 100 MG Oral TabletPSN04e1c5f8-de7e-8ce7-e063-6394a90acc574
856773amitriptyline HCl 150 MG Oral TabletPSN04e1c5f8-de7e-8ce7-e063-6394a90acc574
856834amitriptyline HCl 25 MG Oral TabletPSN04e1c5f8-de7e-8ce7-e063-6394a90acc574
856834amitriptyline HCl 25 MG Oral TabletPSN541ba74a-babb-4731-a5ef-fe7c18992c0b4
856845amitriptyline HCl 50 MG Oral TabletPSN04e1c5f8-de7e-8ce7-e063-6394a90acc574
856853amitriptyline HCl 75 MG Oral TabletPSN04e1c5f8-de7e-8ce7-e063-6394a90acc574
856783amitriptyline hydrochloride 10 MG Oral TabletSCD04e1c5f8-de7e-8ce7-e063-6394a90acc574
856762amitriptyline hydrochloride 100 MG Oral TabletSCD04e1c5f8-de7e-8ce7-e063-6394a90acc574
856773amitriptyline hydrochloride 150 MG Oral TabletSCD04e1c5f8-de7e-8ce7-e063-6394a90acc574
856834amitriptyline hydrochloride 25 MG Oral TabletSCD04e1c5f8-de7e-8ce7-e063-6394a90acc574
856834amitriptyline hydrochloride 25 MG Oral TabletSCD541ba74a-babb-4731-a5ef-fe7c18992c0b4
856845amitriptyline hydrochloride 50 MG Oral TabletSCD04e1c5f8-de7e-8ce7-e063-6394a90acc574
856853amitriptyline hydrochloride 75 MG Oral TabletSCD04e1c5f8-de7e-8ce7-e063-6394a90acc574

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57664-688-18576640688181000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-688-18) 1987-07-140000-00-00NoNoCurrent
57664-688-8857664068888100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-688-88) 1987-07-140000-00-00NoNoCurrent