FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
69367-390
11-digit product format
693670390
Labeler code
69367
Product ID
69367-390_3991983c-6f46-46e2-825c-ed9e5d4c1cb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA212654
Marketing category
ANDA
Marketing start
2024-05-20
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 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
69367-390-01Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, COATED1002
69367-390-10Amitriptyline Hydrochloride1000 in 1 BOTTLETABLET, COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-390-01EA - Each69367-3901d7b5607-a1d8-4d0b-b861-beb7d4ae3ad112024-07-12
69367-390-10EA - Each69367-390517f214f-2127-419e-bc25-cee7ac576ce912024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-390AMITRIPTYLINE HYDROCHLORIDE TABLET, COATED [WESTMINSTER PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20240526_d46ff585-7082-4a7c-a88f-2acf3be0f1d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN56379133-cd11-4dff-b511-7cdfc9a360ca3
856845amitriptyline HCl 50 MG Oral TabletPSN5fe84552-9650-42e4-9870-add97b46dfe13
856845amitriptyline hydrochloride 50 MG Oral TabletSCD5fe84552-9650-42e4-9870-add97b46dfe13
856845amitriptyline hydrochloride 50 MG Oral TabletSCD56379133-cd11-4dff-b511-7cdfc9a360ca3
856783amitriptyline HCl 10 MG Oral TabletPSNd46ff585-7082-4a7c-a88f-2acf3be0f1d52
856762amitriptyline HCl 100 MG Oral TabletPSNd46ff585-7082-4a7c-a88f-2acf3be0f1d52
856773amitriptyline HCl 150 MG Oral TabletPSNd46ff585-7082-4a7c-a88f-2acf3be0f1d52
856834amitriptyline HCl 25 MG Oral TabletPSNd46ff585-7082-4a7c-a88f-2acf3be0f1d52
856845amitriptyline HCl 50 MG Oral TabletPSNd46ff585-7082-4a7c-a88f-2acf3be0f1d52
856853amitriptyline HCl 75 MG Oral TabletPSNd46ff585-7082-4a7c-a88f-2acf3be0f1d52
856783amitriptyline hydrochloride 10 MG Oral TabletSCDd46ff585-7082-4a7c-a88f-2acf3be0f1d52
856762amitriptyline hydrochloride 100 MG Oral TabletSCDd46ff585-7082-4a7c-a88f-2acf3be0f1d52
856773amitriptyline hydrochloride 150 MG Oral TabletSCDd46ff585-7082-4a7c-a88f-2acf3be0f1d52
856834amitriptyline hydrochloride 25 MG Oral TabletSCDd46ff585-7082-4a7c-a88f-2acf3be0f1d52
856845amitriptyline hydrochloride 50 MG Oral TabletSCDd46ff585-7082-4a7c-a88f-2acf3be0f1d52
856853amitriptyline hydrochloride 75 MG Oral TabletSCDd46ff585-7082-4a7c-a88f-2acf3be0f1d52
856845amitriptyline HCl 50 MG Oral TabletPSNdb4d83b8-3ce7-433e-b32a-a8dc2f44b9091
856845amitriptyline hydrochloride 50 MG Oral TabletSCDdb4d83b8-3ce7-433e-b32a-a8dc2f44b9091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-390-0169367039001100 TABLET, COATED in 1 BOTTLE (69367-390-01) 2024-05-20NoNoHistorical
69367-390-10693670390101000 TABLET, COATED in 1 BOTTLE (69367-390-10) 2024-05-20NoNoHistorical