Nortriptyline Hydrochloride

Product NDC
67046-1661
11-digit product format
670461661
Labeler code
67046
Product ID
67046-1661_4c21abdb-f3d8-9037-e063-6294a90af4b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA074132
Marketing category
ANDA
Marketing start
2026-03-03
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nortriptyline Hydrochloride
Listing expiration
2027-12-31

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
67046-1661-3Nortriptyline Hydrochloride30 in 1 BLISTER PACKCAPSULE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSN4c21abdb-f3e9-9037-e063-6294a90af4b41
317136nortriptyline 25 MG Oral CapsuleSCD4c21abdb-f3e9-9037-e063-6294a90af4b41
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY4c21abdb-f3e9-9037-e063-6294a90af4b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1661-36704616610330 CAPSULE in 1 BLISTER PACK (67046-1661-3) 30 capsule2026-03-03NoNoCurrent