Nortriptyline Hydrochloride

Product NDC
50436-6652
11-digit product format
504366652
Labeler code
50436
Product ID
50436-6652_e7a205f3-bb66-4c1b-826d-4d34c8f09d81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA073553
Marketing category
ANDA
Marketing start
1992-07-01
Marketing end
0000-00-00
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-6652-12020-01-31C16284748780-19d75b9d0-e10d-f424-e053-dadaa90a57ceRevised: March 2013 Nortriptyline Hydrochloride Capsules USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6652-1Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6652-1EA - Each50436-66523bc4a25f-ea36-4835-a011-41d0f3ca58e812014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORTRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
NORTRIPTYLINEACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8NORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
GELATININACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6652NORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]3Legacy NDC, 1 package rows20131210_76fb3847-abd1-493a-b3eb-7db4801401e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSN76fb3847-abd1-493a-b3eb-7db4801401e73
198045nortriptyline 10 MG Oral CapsuleSCD76fb3847-abd1-493a-b3eb-7db4801401e73
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY76fb3847-abd1-493a-b3eb-7db4801401e73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6652-15043666520130 in 1 BOTTLEHistorical