Nortriptyline Hydrochloride

Product NDC
70518-4017
11-digit product format
705184017
Labeler code
70518
Product ID
70518-4017_3f906a91-9a16-c7d6-e063-6394a90ab4d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA074132
Marketing category
ANDA
Marketing start
2024-02-09
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198045

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
70518-4017-0Nortriptyline Hydrochloride30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4017NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]1Current NDC, 1 package rows20240213_dd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNdd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2
198045nortriptyline 10 MG Oral CapsuleSCDdd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYdd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4017-07051840170030 CAPSULE in 1 BLISTER PACK (70518-4017-0) 30 capsule2024-02-09NoNoCurrent