Nortriptyline Hydrochloride

Product NDC
33261-532
11-digit product format
332610532
Labeler code
33261
Product ID
33261-532_fed33441-965f-40ad-af22-e32244a884cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
33261-532-302020-01-31C16284748780-19d75b9d1-2505-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules USP Revised: March 2013 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-532-30Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-532-30EA - Each33261-532a1751b9c-10b6-4675-9b66-a0da300e568212015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-532NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140128_7b37afca-bf1f-439e-92ca-7507b88a5e9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSN7b37afca-bf1f-439e-92ca-7507b88a5e9f1
198045nortriptyline 10 MG Oral CapsuleSCD7b37afca-bf1f-439e-92ca-7507b88a5e9f1
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY7b37afca-bf1f-439e-92ca-7507b88a5e9f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-532-303326105323030 in 1 BOTTLE, PLASTICHistorical