FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
50090-7191
11-digit product format
500907191
Labeler code
50090
Product ID
50090-7191_3c541495-105a-47ea-9486-02597695958f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA073556
Marketing category
ANDA
Marketing start
2023-11-17
Substance
NORTRIPTYLINE 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
Nortriptyline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui317136

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7191-0Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE302
50090-7191-3Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7191-0EA - Each50090-7191be39a391-ceb5-4adf-8d4c-afaedd055ea012024-08-12
50090-7191-3EA - Each50090-7191896f3c4a-1ced-46e8-9209-a9ab33a1da1012024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7191NORTRIPTYLINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]2Current NDC, 2 package rows20240712_8a294b63-7268-4105-8e17-a59ef889d572.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSN8a294b63-7268-4105-8e17-a59ef889d5722
317136nortriptyline 25 MG Oral CapsuleSCD8a294b63-7268-4105-8e17-a59ef889d5722
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY8a294b63-7268-4105-8e17-a59ef889d5722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7191-05009071910030 CAPSULE in 1 BOTTLE (50090-7191-0) 30 capsule2024-07-08NoNoCurrent
50090-7191-35009071910390 CAPSULE in 1 BOTTLE (50090-7191-3) 90 capsule2024-07-08NoNoCurrent