FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
29300-420
11-digit product format
293000420
Labeler code
29300
Product ID
29300-420_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
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
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-420-01Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
29300-420-05Amitriptyline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006
29300-420-10Amitriptyline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-420-01EA - Each29300-420dbecc562-cc58-4c50-a219-b1a956dd8be812021-08-05
29300-420-10EA - Each29300-4209a5df32b-1f87-436b-8a6d-e3b7ac71b82112021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-420AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5Current NDC, Legacy NDC, 3 package rows20250327_9c6e0e05-b579-4fae-b768-e1a664c39bb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSN6a176cd7-7c13-440e-b6bb-dc2fab3f2a12102
856834amitriptyline hydrochloride 25 MG Oral TabletSCD6a176cd7-7c13-440e-b6bb-dc2fab3f2a12102
856834amitriptyline HCl 25 MG Oral TabletPSN451b8742-8b3c-4335-9075-c1d8313cd3d09
856834amitriptyline hydrochloride 25 MG Oral TabletSCD451b8742-8b3c-4335-9075-c1d8313cd3d09
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
856834amitriptyline HCl 25 MG Oral TabletPSNc66e9088-4f34-4b97-971e-5272b45cfc976
856834amitriptyline HCl 25 MG Oral TabletPSNbbbd535d-0bce-469e-917f-70a6ebd2f0076
856834amitriptyline HCl 25 MG Oral TabletPSNf420498a-bfcc-4549-e053-2995a90a7b096
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 TabletSCDf420498a-bfcc-4549-e053-2995a90a7b096
856834amitriptyline hydrochloride 25 MG Oral TabletSCDbbbd535d-0bce-469e-917f-70a6ebd2f0076
856834amitriptyline hydrochloride 25 MG Oral TabletSCD9c6e0e05-b579-4fae-b768-e1a664c39bb86
856834amitriptyline hydrochloride 25 MG Oral TabletSCDc66e9088-4f34-4b97-971e-5272b45cfc976
856845amitriptyline hydrochloride 50 MG Oral TabletSCD9c6e0e05-b579-4fae-b768-e1a664c39bb86
856853amitriptyline hydrochloride 75 MG Oral TabletSCD9c6e0e05-b579-4fae-b768-e1a664c39bb86
856834amitriptyline HCl 25 MG Oral TabletPSNba6a83c4-2993-40ca-bb8f-2d6c5c3e3e264
856834amitriptyline HCl 25 MG Oral TabletPSN69c7a0bd-93d0-40fe-a6d3-f41986b802b44
856834amitriptyline hydrochloride 25 MG Oral TabletSCD69c7a0bd-93d0-40fe-a6d3-f41986b802b44
856834amitriptyline hydrochloride 25 MG Oral TabletSCDba6a83c4-2993-40ca-bb8f-2d6c5c3e3e264
856783amitriptyline HCl 10 MG Oral TabletPSNfd771b4b-c7ae-8e69-e053-6294a90a21202
856834amitriptyline HCl 25 MG Oral TabletPSNcaff227d-bb73-435f-80a0-94c51a81117a2
856834amitriptyline HCl 25 MG Oral TabletPSNf98d25a7-6b47-38a9-e053-6394a90a541d2
856834amitriptyline HCl 25 MG Oral TabletPSNfd771b4b-c7ae-8e69-e053-6294a90a21202
856834amitriptyline HCl 25 MG Oral TabletPSN43450e62-d8c1-b39e-e063-6294a90a42ee2
856845amitriptyline HCl 50 MG Oral TabletPSNfd771b4b-c7ae-8e69-e053-6294a90a21202
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 TabletSCDcaff227d-bb73-435f-80a0-94c51a81117a2
856834amitriptyline hydrochloride 25 MG Oral TabletSCDf98d25a7-6b47-38a9-e053-6394a90a541d2
856834amitriptyline hydrochloride 25 MG Oral TabletSCDfd771b4b-c7ae-8e69-e053-6294a90a21202
856834amitriptyline hydrochloride 25 MG Oral TabletSCD43450e62-d8c1-b39e-e063-6294a90a42ee2
856845amitriptyline hydrochloride 50 MG Oral TabletSCDfd771b4b-c7ae-8e69-e053-6294a90a21202
856853amitriptyline hydrochloride 75 MG Oral TabletSCDfd771b4b-c7ae-8e69-e053-6294a90a21202
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 TabletPSN8746c047-51b9-4040-aeec-cd1f5b6eb3d41
856834amitriptyline HCl 25 MG Oral TabletPSN776d2c2c-d897-4da1-a99a-b4324e1f864f1
856834amitriptyline HCl 25 MG Oral TabletPSNf6914a05-6a47-2ffb-e053-2a95a90a8e171
856834amitriptyline HCl 25 MG Oral TabletPSNce665435-b2f1-4fcd-ae20-4f372f3760951
856834amitriptyline HCl 25 MG Oral TabletPSN14a883b6-4fc4-a7c6-e063-6394a90a82f21
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
856773amitriptyline hydrochloride 150 MG Oral TabletSCD776d2c2c-d897-4da1-a99a-b4324e1f864f1
856834amitriptyline hydrochloride 25 MG Oral TabletSCD8746c047-51b9-4040-aeec-cd1f5b6eb3d41
856834amitriptyline hydrochloride 25 MG Oral TabletSCD14a883b6-4fc4-a7c6-e063-6394a90a82f21
856834amitriptyline hydrochloride 25 MG Oral TabletSCDf6914a05-6a47-2ffb-e053-2a95a90a8e171
856834amitriptyline hydrochloride 25 MG Oral TabletSCDce665435-b2f1-4fcd-ae20-4f372f3760951
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
29300-420-0129300042001100 TABLET, FILM COATED in 1 BOTTLE (29300-420-01) 2021-05-260000-00-00NoNoCurrent
29300-420-0529300042005500 TABLET, FILM COATED in 1 BOTTLE (29300-420-05) 2021-05-260000-00-00NoNoCurrent
29300-420-10293000420101000 TABLET, FILM COATED in 1 BOTTLE (29300-420-10) 2021-11-160000-00-00NoNoCurrent