FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
29300-423
11-digit product format
293000423
Labeler code
29300
Product ID
29300-423_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
100 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 HYDROCHLORIDE100 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
29300-423-01Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
29300-423-05Amitriptyline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-423-01EA - Each29300-423edfbd566-445b-4348-a919-0ec71c9bd4c212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-423AMITRIPTYLINE 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
856762amitriptyline HCl 100 MG Oral TabletPSN86bad1a5-48c3-4a8a-970f-8fdbda078b4e101
856762amitriptyline hydrochloride 100 MG Oral TabletSCD86bad1a5-48c3-4a8a-970f-8fdbda078b4e101
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
856762amitriptyline HCl 100 MG Oral TabletPSNcf03c1a1-cbd5-47dc-a5e8-70ec32b71cb15
856762amitriptyline hydrochloride 100 MG Oral TabletSCDcf03c1a1-cbd5-47dc-a5e8-70ec32b71cb15
856762amitriptyline HCl 100 MG Oral TabletPSNf78102eb-cbeb-801a-e053-6294a90ab8803
856762amitriptyline hydrochloride 100 MG Oral TabletSCDf78102eb-cbeb-801a-e053-6294a90ab8803
856762amitriptyline HCl 100 MG Oral TabletPSNf5c5f3b6-e92b-1120-e053-2995a90ae8fa2
856762amitriptyline hydrochloride 100 MG Oral TabletSCDf5c5f3b6-e92b-1120-e053-2995a90ae8fa2
856783amitriptyline HCl 10 MG Oral TabletPSN776d2c2c-d897-4da1-a99a-b4324e1f864f1
856762amitriptyline HCl 100 MG Oral TabletPSN1a622039-0a79-407c-8f15-2ea0c58441361
856762amitriptyline HCl 100 MG Oral TabletPSN776d2c2c-d897-4da1-a99a-b4324e1f864f1
856762amitriptyline HCl 100 MG Oral TabletPSN1b2d2bb8-78c8-7e8e-e063-6294a90a25761
856762amitriptyline HCl 100 MG Oral TabletPSN50375dab-97fe-8c84-e063-6394a90a60b21
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 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
856762amitriptyline hydrochloride 100 MG Oral TabletSCD50375dab-97fe-8c84-e063-6394a90a60b21
856762amitriptyline hydrochloride 100 MG Oral TabletSCD1b2d2bb8-78c8-7e8e-e063-6294a90a25761
856762amitriptyline hydrochloride 100 MG Oral TabletSCD1a622039-0a79-407c-8f15-2ea0c58441361
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-423-0129300042301100 TABLET, FILM COATED in 1 BOTTLE (29300-423-01) 2021-05-260000-00-00NoNoCurrent
29300-423-0529300042305500 TABLET, FILM COATED in 1 BOTTLE (29300-423-05) 2021-05-260000-00-00NoNoCurrent