FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
71610-785
11-digit product format
716100785
Labeler code
71610
Product ID
71610-785_694842c0-33b2-4cd4-adf7-2dd8999b38ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074132
Marketing category
ANDA
Marketing start
1995-04-06
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
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-785-30Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE301
71610-785-60Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-785-30EA - Each71610-7850d47cc18-c708-498f-813b-05e6bfabbba612024-03-12
71610-785-60EA - Each71610-785f75d28ed-a857-4f39-9799-66195ab893ab12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-785NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 2 package rows20240206_f1868790-c70b-4979-974d-3ce0ffe99e36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSNf1868790-c70b-4979-974d-3ce0ffe99e361
317136nortriptyline 25 MG Oral CapsuleSCDf1868790-c70b-4979-974d-3ce0ffe99e361
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYf1868790-c70b-4979-974d-3ce0ffe99e361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-785-307161007853030 CAPSULE in 1 BOTTLE (71610-785-30) 30 capsule2024-01-26NoNoHistorical
71610-785-607161007856090 CAPSULE in 1 BOTTLE (71610-785-60) 90 capsule2024-01-26NoNoHistorical