Nortriptyline Hydrochloride

Product NDC
70518-4281
11-digit product format
705184281
Labeler code
70518
Product ID
70518-4281_4019e178-822a-7317-e063-6394a90a7422
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA073556
Marketing category
ANDA
Marketing start
2025-02-08
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198047

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4281-0Nortriptyline Hydrochloride30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4281NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]1Current NDC, 1 package rows20250213_4852a754-2fc1-4c10-a414-dc8a1dfd66a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198047nortriptyline HCl 75 MG Oral CapsulePSN4852a754-2fc1-4c10-a414-dc8a1dfd66a22
198047nortriptyline 75 MG Oral CapsuleSCD4852a754-2fc1-4c10-a414-dc8a1dfd66a22
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSY4852a754-2fc1-4c10-a414-dc8a1dfd66a22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4281-07051842810030 CAPSULE in 1 BLISTER PACK (70518-4281-0) 30 capsule2025-02-08NoNoCurrent