FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
29300-422
11-digit product format
293000422
Labeler code
29300
Product ID
29300-422_3f6bcdb5-c8ad-45c0-b43f-2dbea8980376
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA214548
Marketing category
ANDA
Marketing start
2021-05-26
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 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
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-422-01Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
29300-422-05Amitriptyline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-422-01EA - Each29300-4223b29f873-a274-4698-9e88-3ca82afd6bd512021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-422AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5Current NDC, Legacy NDC, 2 package rows20250327_9c6e0e05-b579-4fae-b768-e1a664c39bb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856853amitriptyline HCl 75 MG Oral TabletPSN2bda8478-f5ab-440a-a8a3-61ebc5721369101
856853amitriptyline hydrochloride 75 MG Oral TabletSCD2bda8478-f5ab-440a-a8a3-61ebc5721369101
856783amitriptyline HCl 10 MG Oral TabletPSN9c6e0e05-b579-4fae-b768-e1a664c39bb86
856762amitriptyline HCl 100 MG Oral TabletPSN9c6e0e05-b579-4fae-b768-e1a664c39bb86
856773amitriptyline HCl 150 MG Oral TabletPSN9c6e0e05-b579-4fae-b768-e1a664c39bb86
856834amitriptyline HCl 25 MG Oral TabletPSN9c6e0e05-b579-4fae-b768-e1a664c39bb86
856845amitriptyline HCl 50 MG Oral TabletPSN9c6e0e05-b579-4fae-b768-e1a664c39bb86
856853amitriptyline HCl 75 MG Oral TabletPSN9c6e0e05-b579-4fae-b768-e1a664c39bb86
856783amitriptyline hydrochloride 10 MG Oral TabletSCD9c6e0e05-b579-4fae-b768-e1a664c39bb86
856762amitriptyline hydrochloride 100 MG Oral TabletSCD9c6e0e05-b579-4fae-b768-e1a664c39bb86
856773amitriptyline hydrochloride 150 MG Oral TabletSCD9c6e0e05-b579-4fae-b768-e1a664c39bb86
856834amitriptyline hydrochloride 25 MG Oral TabletSCD9c6e0e05-b579-4fae-b768-e1a664c39bb86
856845amitriptyline hydrochloride 50 MG Oral TabletSCD9c6e0e05-b579-4fae-b768-e1a664c39bb86
856853amitriptyline hydrochloride 75 MG Oral TabletSCD9c6e0e05-b579-4fae-b768-e1a664c39bb86
856853amitriptyline HCl 75 MG Oral TabletPSN8b10ac1a-cf66-4efa-9abc-498b2f8a16134
856853amitriptyline hydrochloride 75 MG Oral TabletSCD8b10ac1a-cf66-4efa-9abc-498b2f8a16134
856853amitriptyline HCl 75 MG Oral TabletPSN9ced0126-d597-48fb-96d3-5773337600483
856853amitriptyline hydrochloride 75 MG Oral TabletSCD9ced0126-d597-48fb-96d3-5773337600483
856783amitriptyline HCl 10 MG Oral TabletPSNfd771b4b-c7ae-8e69-e053-6294a90a21202
856834amitriptyline HCl 25 MG Oral TabletPSNfd771b4b-c7ae-8e69-e053-6294a90a21202
856845amitriptyline HCl 50 MG Oral TabletPSNfd771b4b-c7ae-8e69-e053-6294a90a21202
856853amitriptyline HCl 75 MG Oral TabletPSNf6dc463b-3601-48c0-e053-6294a90a2d772
856853amitriptyline HCl 75 MG Oral TabletPSNfd771b4b-c7ae-8e69-e053-6294a90a21202
856783amitriptyline hydrochloride 10 MG Oral TabletSCDfd771b4b-c7ae-8e69-e053-6294a90a21202
856834amitriptyline hydrochloride 25 MG Oral TabletSCDfd771b4b-c7ae-8e69-e053-6294a90a21202
856845amitriptyline hydrochloride 50 MG Oral TabletSCDfd771b4b-c7ae-8e69-e053-6294a90a21202
856853amitriptyline hydrochloride 75 MG Oral TabletSCDfd771b4b-c7ae-8e69-e053-6294a90a21202
856853amitriptyline hydrochloride 75 MG Oral TabletSCDf6dc463b-3601-48c0-e053-6294a90a2d772
856783amitriptyline HCl 10 MG Oral TabletPSN776d2c2c-d897-4da1-a99a-b4324e1f864f1
856762amitriptyline HCl 100 MG Oral TabletPSN776d2c2c-d897-4da1-a99a-b4324e1f864f1
856773amitriptyline HCl 150 MG Oral TabletPSN776d2c2c-d897-4da1-a99a-b4324e1f864f1
856834amitriptyline HCl 25 MG Oral TabletPSN776d2c2c-d897-4da1-a99a-b4324e1f864f1
856845amitriptyline HCl 50 MG Oral TabletPSN776d2c2c-d897-4da1-a99a-b4324e1f864f1
856853amitriptyline HCl 75 MG Oral TabletPSN6dc9d113-1156-43ec-a7eb-253c2ff6bcfa1
856853amitriptyline HCl 75 MG Oral TabletPSN776d2c2c-d897-4da1-a99a-b4324e1f864f1
856783amitriptyline hydrochloride 10 MG Oral TabletSCD776d2c2c-d897-4da1-a99a-b4324e1f864f1
856762amitriptyline hydrochloride 100 MG Oral TabletSCD776d2c2c-d897-4da1-a99a-b4324e1f864f1
856773amitriptyline hydrochloride 150 MG Oral TabletSCD776d2c2c-d897-4da1-a99a-b4324e1f864f1
856834amitriptyline hydrochloride 25 MG Oral TabletSCD776d2c2c-d897-4da1-a99a-b4324e1f864f1
856845amitriptyline hydrochloride 50 MG Oral TabletSCD776d2c2c-d897-4da1-a99a-b4324e1f864f1
856853amitriptyline hydrochloride 75 MG Oral TabletSCD776d2c2c-d897-4da1-a99a-b4324e1f864f1
856853amitriptyline hydrochloride 75 MG Oral TabletSCD6dc9d113-1156-43ec-a7eb-253c2ff6bcfa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-422-0129300042201100 TABLET, FILM COATED in 1 BOTTLE (29300-422-01) 2021-05-260000-00-00NoNoCurrent
29300-422-0529300042205500 TABLET, FILM COATED in 1 BOTTLE (29300-422-05) 2021-05-260000-00-00NoNoCurrent