Nortriptyline Hydrochloride

Product NDC
33261-692
11-digit product format
332610692
Labeler code
33261
Product ID
33261-692_7f8fad0a-267b-4284-9de3-14ddd77d9ac0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA074132
Marketing category
ANDA
Marketing start
1995-04-05
Marketing end
0000-00-00
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 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
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-692-30Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301
33261-692-60Nortriptyline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-692-30EA - Each33261-692fdc5baa0-6888-4a2e-9197-e8ee78cb53b112015-10-02
33261-692-60EA - Each33261-692759bfe8b-532d-4bf6-8b02-18ef27e28c3512015-10-02

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
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE 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
33261-692NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140128_79d0c09a-8557-44a2-bb87-2ddc496edc1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSN79d0c09a-8557-44a2-bb87-2ddc496edc1b1
198046nortriptyline HCl 50 MG Oral CapsulePSN79d0c09a-8557-44a2-bb87-2ddc496edc1b1
198047nortriptyline HCl 75 MG Oral CapsulePSN79d0c09a-8557-44a2-bb87-2ddc496edc1b1
317136nortriptyline 25 MG Oral CapsuleSCD79d0c09a-8557-44a2-bb87-2ddc496edc1b1
198046nortriptyline 50 MG Oral CapsuleSCD79d0c09a-8557-44a2-bb87-2ddc496edc1b1
198047nortriptyline 75 MG Oral CapsuleSCD79d0c09a-8557-44a2-bb87-2ddc496edc1b1
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY79d0c09a-8557-44a2-bb87-2ddc496edc1b1
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY79d0c09a-8557-44a2-bb87-2ddc496edc1b1
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSY79d0c09a-8557-44a2-bb87-2ddc496edc1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-692-303326106923030 in 1 BOTTLE, PLASTICHistorical
33261-692-603326106926060 in 1 BOTTLE, PLASTICHistorical