FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
21695-600
11-digit product format
216950600
Labeler code
21695
Product ID
21695-600_03601ccc-4a9a-4cb9-9028-281bbed42182
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA073556
Marketing category
ANDA
Marketing start
1992-03-30
Marketing end
0000-00-00
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
75 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-600-302019-09-24C16284748780-1934fe258-4767-48b1-e053-8cdaa90a720aNortriptyline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-600-30Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-600-30EA - Each21695-600d4c76d20-11bb-4c40-b8e6-5e3eeace19cf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORTRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
NORTRIPTYLINEACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
GELATININACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-600NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2Legacy NDC, 1 package rows20110805_375f06ce-97ea-4b4c-8d90-6b2091be18fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSN375f06ce-97ea-4b4c-8d90-6b2091be18fa2
317136nortriptyline HCl 25 MG Oral CapsulePSN375f06ce-97ea-4b4c-8d90-6b2091be18fa2
198046nortriptyline HCl 50 MG Oral CapsulePSN375f06ce-97ea-4b4c-8d90-6b2091be18fa2
198047nortriptyline HCl 75 MG Oral CapsulePSN375f06ce-97ea-4b4c-8d90-6b2091be18fa2
198045nortriptyline 10 MG Oral CapsuleSCD375f06ce-97ea-4b4c-8d90-6b2091be18fa2
317136nortriptyline 25 MG Oral CapsuleSCD375f06ce-97ea-4b4c-8d90-6b2091be18fa2
198046nortriptyline 50 MG Oral CapsuleSCD375f06ce-97ea-4b4c-8d90-6b2091be18fa2
198047nortriptyline 75 MG Oral CapsuleSCD375f06ce-97ea-4b4c-8d90-6b2091be18fa2
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY375f06ce-97ea-4b4c-8d90-6b2091be18fa2
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY375f06ce-97ea-4b4c-8d90-6b2091be18fa2
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY375f06ce-97ea-4b4c-8d90-6b2091be18fa2
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSY375f06ce-97ea-4b4c-8d90-6b2091be18fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-600-302169506003030 in 1 BOTTLEHistorical