Nortriptyline Hydrochloride

Product NDC
10544-567
11-digit product format
105440567
Labeler code
10544
Product ID
10544-567_11b89d5f-c5c7-37b8-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA073553
Marketing category
ANDA
Marketing start
2013-11-14
Marketing end
0000-00-00
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-567-60Nortriptyline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE601
10544-567-90Nortriptyline Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-567-60EA - Each10544-567c44b0d38-0f11-4d4f-ae41-118471df6b0f12015-10-02
10544-567-90EA - Each10544-567e0f8b7fa-fda7-430f-bbc5-cb327e91fe5012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORTRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
NORTRIPTYLINEACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-567NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20150320_11b89d5f-c5c6-37b8-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSN11b89d5f-c5c6-37b8-e054-00144ff88e881
198045nortriptyline 10 MG Oral CapsuleSCD11b89d5f-c5c6-37b8-e054-00144ff88e881
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY11b89d5f-c5c6-37b8-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-567-601054405676060 in 1 BOTTLE, PLASTICHistorical
10544-567-901054405679090 in 1 BOTTLE, PLASTICHistorical