FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
0093-0810
11-digit product format
000930810
Labeler code
0093
Product ID
0093-0810_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
10 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 HYDROCHLORIDE10 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
0093-0810-01Nortriptyline Hydrochloride100 in 1 BOTTLECAPSULE10023
0093-0810-05Nortriptyline Hydrochloride500 in 1 BOTTLECAPSULE50023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0810-01EA - Each0093-08107d5cd21a-4d14-4760-a712-6bc55ec7d32f12012-07-24
0093-0810-05EA - Each0093-08100eacbcb2-9542-4d6e-9b48-c87a2b3e5cef12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORTRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
NORTRIPTYLINEACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
GELATININACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
SHELLACINACTIVE INGREDIENT46N107B71ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
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 [DISPENSING SOLUTIONS, INC.]3
NORTRIPTYLINEACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3
NORTRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
NORTRIPTYLINEACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-0810NORTRIPTYLINE 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 CapsulePSN43a81887-42b8-43b5-b58a-3f3df2e9949b1009
198045nortriptyline 10 MG Oral CapsuleSCD43a81887-42b8-43b5-b58a-3f3df2e9949b1009
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY43a81887-42b8-43b5-b58a-3f3df2e9949b1009
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
198045nortriptyline HCl 10 MG Oral CapsulePSN017f7717-e160-4142-9a5a-1a2bd97767075
317136nortriptyline HCl 25 MG Oral CapsulePSN017f7717-e160-4142-9a5a-1a2bd97767075
198045nortriptyline 10 MG Oral CapsuleSCD017f7717-e160-4142-9a5a-1a2bd97767075
317136nortriptyline 25 MG Oral CapsuleSCD017f7717-e160-4142-9a5a-1a2bd97767075
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY017f7717-e160-4142-9a5a-1a2bd97767075
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY017f7717-e160-4142-9a5a-1a2bd97767075
198045nortriptyline HCl 10 MG Oral CapsulePSN686d15d0-6434-42ec-8c78-f45d617d294c3
198045nortriptyline HCl 10 MG Oral CapsulePSNf0ade32e-ac28-4d81-85a6-4eb55a39ce653
198045nortriptyline 10 MG Oral CapsuleSCDf0ade32e-ac28-4d81-85a6-4eb55a39ce653
198045nortriptyline 10 MG Oral CapsuleSCD686d15d0-6434-42ec-8c78-f45d617d294c3
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYf0ade32e-ac28-4d81-85a6-4eb55a39ce653
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY686d15d0-6434-42ec-8c78-f45d617d294c3
198045nortriptyline HCl 10 MG Oral CapsulePSNa817877d-d9cf-4c81-b65e-c56c9b126eef2
198045nortriptyline HCl 10 MG Oral CapsulePSNdd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2
198045nortriptyline 10 MG Oral CapsuleSCDdd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2
198045nortriptyline 10 MG Oral CapsuleSCDa817877d-d9cf-4c81-b65e-c56c9b126eef2
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYdd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYa817877d-d9cf-4c81-b65e-c56c9b126eef2
198045nortriptyline HCl 10 MG Oral CapsulePSNd111c36d-98ed-4f0d-97ea-86fe9048deee1
198045nortriptyline HCl 10 MG Oral CapsulePSN30263e15-de21-4db4-aceb-59d619909e821
317136nortriptyline HCl 25 MG Oral CapsulePSNd111c36d-98ed-4f0d-97ea-86fe9048deee1
198045nortriptyline 10 MG Oral CapsuleSCD30263e15-de21-4db4-aceb-59d619909e821
198045nortriptyline 10 MG Oral CapsuleSCDd111c36d-98ed-4f0d-97ea-86fe9048deee1
317136nortriptyline 25 MG Oral CapsuleSCDd111c36d-98ed-4f0d-97ea-86fe9048deee1
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYd111c36d-98ed-4f0d-97ea-86fe9048deee1
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY30263e15-de21-4db4-aceb-59d619909e821
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYd111c36d-98ed-4f0d-97ea-86fe9048deee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-0810-0100093081001100 CAPSULE in 1 BOTTLE (0093-0810-01) 100 capsule1995-04-050000-00-00NoNoCurrent
0093-0810-0500093081005500 CAPSULE in 1 BOTTLE (0093-0810-05) 500 capsule1995-04-050000-00-00NoNoCurrent