FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
0093-0813
11-digit product format
000930813
Labeler code
0093
Product ID
0093-0813_314d74dc-7394-40b9-be81-cb67b6e925a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA074132
Marketing category
ANDA
Marketing start
1995-04-05
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nortriptyline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198045, 198046, 198047, 317136

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-0813-01Nortriptyline Hydrochloride100 in 1 BOTTLECAPSULE10023
0093-0813-05Nortriptyline Hydrochloride500 in 1 BOTTLECAPSULE50023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0813-01EA - Each0093-08132e2f0723-1e07-41a1-9f50-beeeab0caf2b12012-07-24
0093-0813-05EA - Each0093-0813d6c71b10-d581-49cb-a9a3-e1ee83c958cb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORTRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
NORTRIPTYLINEACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
GELATININACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
SHELLACINACTIVE INGREDIENT46N107B71ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]11
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
0093-0813NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]22Current NDC, Legacy NDC, 2 package rows20250522_b58d473a-b19f-4d2a-b1ae-dd398d7a29e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNb58d473a-b19f-4d2a-b1ae-dd398d7a29e123
317136nortriptyline HCl 25 MG Oral CapsulePSNb58d473a-b19f-4d2a-b1ae-dd398d7a29e123
198046nortriptyline HCl 50 MG Oral CapsulePSNb58d473a-b19f-4d2a-b1ae-dd398d7a29e123
198047nortriptyline HCl 75 MG Oral CapsulePSNb58d473a-b19f-4d2a-b1ae-dd398d7a29e123
198045nortriptyline 10 MG Oral CapsuleSCDb58d473a-b19f-4d2a-b1ae-dd398d7a29e123
317136nortriptyline 25 MG Oral CapsuleSCDb58d473a-b19f-4d2a-b1ae-dd398d7a29e123
198046nortriptyline 50 MG Oral CapsuleSCDb58d473a-b19f-4d2a-b1ae-dd398d7a29e123
198047nortriptyline 75 MG Oral CapsuleSCDb58d473a-b19f-4d2a-b1ae-dd398d7a29e123
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYb58d473a-b19f-4d2a-b1ae-dd398d7a29e123
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYb58d473a-b19f-4d2a-b1ae-dd398d7a29e123
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYb58d473a-b19f-4d2a-b1ae-dd398d7a29e123
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYb58d473a-b19f-4d2a-b1ae-dd398d7a29e123
198047nortriptyline HCl 75 MG Oral CapsulePSN2f9fc7a0-163a-4a05-84a7-7999a41ecb1f6
198047nortriptyline HCl 75 MG Oral CapsulePSN962f3f54-0556-4509-a231-ca62cb01bec86
198047nortriptyline 75 MG Oral CapsuleSCD962f3f54-0556-4509-a231-ca62cb01bec86
198047nortriptyline 75 MG Oral CapsuleSCD2f9fc7a0-163a-4a05-84a7-7999a41ecb1f6
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSY962f3f54-0556-4509-a231-ca62cb01bec86
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSY2f9fc7a0-163a-4a05-84a7-7999a41ecb1f6
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-0813-0100093081301100 CAPSULE in 1 BOTTLE (0093-0813-01) 100 capsule1995-04-050000-00-00NoNoCurrent
0093-0813-0500093081305500 CAPSULE in 1 BOTTLE (0093-0813-05) 500 capsule1995-04-060000-00-00NoNoCurrent