FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
29300-419
11-digit product format
293000419
Labeler code
29300
Product ID
29300-419_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
10 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 HYDROCHLORIDE10 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
29300-419-01Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
29300-419-05Amitriptyline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006
29300-419-10Amitriptyline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-419-01EA - Each29300-41919163f89-83b9-4615-9bc7-db6d2a3aa60f12021-08-05
29300-419-10EA - Each29300-419a828cf85-47b6-4f04-a219-0d8057751bd312021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-419AMITRIPTYLINE 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
856783amitriptyline HCl 10 MG Oral TabletPSN8c9f605f-ac13-442f-af4d-ea11102474de104
856783amitriptyline hydrochloride 10 MG Oral TabletSCD8c9f605f-ac13-442f-af4d-ea11102474de104
856783amitriptyline HCl 10 MG Oral TabletPSNf6c88d87-66bb-2962-e053-6294a90acfbe7
856783amitriptyline HCl 10 MG Oral TabletPSNabf6a3f5-0df9-4b23-995d-63b973ef80c17
856783amitriptyline hydrochloride 10 MG Oral TabletSCDf6c88d87-66bb-2962-e053-6294a90acfbe7
856783amitriptyline hydrochloride 10 MG Oral TabletSCDabf6a3f5-0df9-4b23-995d-63b973ef80c17
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
856783amitriptyline HCl 10 MG Oral TabletPSN5dd07852-43a5-415c-863e-1202f82b56545
856783amitriptyline HCl 10 MG Oral TabletPSN00d11130-c9ae-4258-9746-9763bc5deb845
856783amitriptyline hydrochloride 10 MG Oral TabletSCD00d11130-c9ae-4258-9746-9763bc5deb845
856783amitriptyline hydrochloride 10 MG Oral TabletSCD5dd07852-43a5-415c-863e-1202f82b56545
856783amitriptyline HCl 10 MG Oral TabletPSNe3dd745a-57f5-4925-e053-2995a90a43c03
856783amitriptyline hydrochloride 10 MG Oral TabletSCDe3dd745a-57f5-4925-e053-2995a90a43c03
856783amitriptyline HCl 10 MG Oral TabletPSN471b99ac-395c-3137-e063-6394a90af18d2
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 TabletPSNfd771b4b-c7ae-8e69-e053-6294a90a21202
856783amitriptyline hydrochloride 10 MG Oral TabletSCDfd771b4b-c7ae-8e69-e053-6294a90a21202
856783amitriptyline hydrochloride 10 MG Oral TabletSCD471b99ac-395c-3137-e063-6394a90af18d2
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
856783amitriptyline HCl 10 MG Oral TabletPSN26a6dde7-a4c1-ced6-e063-6394a90a60311
856783amitriptyline HCl 10 MG Oral TabletPSN18ff2901-08fd-37f0-e063-6394a90a1ad21
856783amitriptyline HCl 10 MG Oral TabletPSNea3c75d9-1718-32e1-e053-2a95a90a3cfe1
856783amitriptyline HCl 10 MG Oral TabletPSNe42bcc34-75ef-5765-e053-2995a90acd191
856783amitriptyline HCl 10 MG Oral TabletPSN61133866-b01c-4278-93fb-4564c1b56e541
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 TabletPSN776d2c2c-d897-4da1-a99a-b4324e1f864f1
856783amitriptyline hydrochloride 10 MG Oral TabletSCD26a6dde7-a4c1-ced6-e063-6394a90a60311
856783amitriptyline hydrochloride 10 MG Oral TabletSCD776d2c2c-d897-4da1-a99a-b4324e1f864f1
856783amitriptyline hydrochloride 10 MG Oral TabletSCD18ff2901-08fd-37f0-e063-6394a90a1ad21
856783amitriptyline hydrochloride 10 MG Oral TabletSCDea3c75d9-1718-32e1-e053-2a95a90a3cfe1
856783amitriptyline hydrochloride 10 MG Oral TabletSCDe42bcc34-75ef-5765-e053-2995a90acd191
856783amitriptyline hydrochloride 10 MG Oral TabletSCD61133866-b01c-4278-93fb-4564c1b56e541
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-419-0129300041901100 TABLET, FILM COATED in 1 BOTTLE (29300-419-01) 2021-05-260000-00-00NoNoCurrent
29300-419-0529300041905500 TABLET, FILM COATED in 1 BOTTLE (29300-419-05) 2021-05-260000-00-00NoNoCurrent
29300-419-10293000419101000 TABLET, FILM COATED in 1 BOTTLE (29300-419-10) 2021-11-160000-00-00NoNoCurrent