FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
51672-4004
11-digit product format
516724004
Labeler code
51672
Product ID
51672-4004_7ff22c22-51b5-4ce3-93ee-8959359fab3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA075520
Marketing category
ANDA
Marketing start
2000-05-08
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
51672-4004-1Nortriptyline Hydrochloride100 in 1 BOTTLECAPSULE10010
51672-4004-2Nortriptyline Hydrochloride500 in 1 BOTTLECAPSULE50010
51672-4004-5Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE9010
51672-4004-6Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4004-1EA - Each51672-400435e9c47b-d08c-4ab8-b1cf-69da7225ecd412016-02-04
51672-4004-2EA - Each51672-40049adc480b-4a07-4b4e-a1a1-6dd34b3f737212015-05-05
51672-4004-5EA - Each51672-40043f1c96c5-552a-43ec-9d69-e74547b96d8c12013-02-13
51672-4004-6EA - Each51672-400437162d6f-2274-453e-862a-dd0996a2a0df12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nortriptyline HydrochlorideACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
NortriptylineACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
aluminum oxideINACTIVE INGREDIENTLMI26O6933NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
D&C Yellow NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
FD&C Blue NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
FD&C Blue NO. 2INACTIVE INGREDIENTL06K8R7DQKNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
FD&C Green NO. 3INACTIVE INGREDIENT3P3ONR6O1SNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOANORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
gelatinINACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
magnesium stearateINACTIVE INGREDIENT70097M6I30NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
shellacINACTIVE INGREDIENT46N107B71ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
starch, cornINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4004NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]10Current NDC, Legacy NDC, 4 package rows20200508_aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNcb4d1a69-60ae-4fdc-8af8-059959cf726516
317136nortriptyline HCl 25 MG Oral CapsulePSNcb4d1a69-60ae-4fdc-8af8-059959cf726516
198046nortriptyline HCl 50 MG Oral CapsulePSNcb4d1a69-60ae-4fdc-8af8-059959cf726516
198047nortriptyline HCl 75 MG Oral CapsulePSNcb4d1a69-60ae-4fdc-8af8-059959cf726516
198045nortriptyline 10 MG Oral CapsuleSCDcb4d1a69-60ae-4fdc-8af8-059959cf726516
317136nortriptyline 25 MG Oral CapsuleSCDcb4d1a69-60ae-4fdc-8af8-059959cf726516
198046nortriptyline 50 MG Oral CapsuleSCDcb4d1a69-60ae-4fdc-8af8-059959cf726516
198047nortriptyline 75 MG Oral CapsuleSCDcb4d1a69-60ae-4fdc-8af8-059959cf726516
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYcb4d1a69-60ae-4fdc-8af8-059959cf726516
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYcb4d1a69-60ae-4fdc-8af8-059959cf726516
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYcb4d1a69-60ae-4fdc-8af8-059959cf726516
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYcb4d1a69-60ae-4fdc-8af8-059959cf726516
198045nortriptyline HCl 10 MG Oral CapsulePSNaee2c1a1-d848-4c3b-8c6d-8a4f6ce94c2810
317136nortriptyline HCl 25 MG Oral CapsulePSNaee2c1a1-d848-4c3b-8c6d-8a4f6ce94c2810
198046nortriptyline HCl 50 MG Oral CapsulePSNaee2c1a1-d848-4c3b-8c6d-8a4f6ce94c2810
198047nortriptyline HCl 75 MG Oral CapsulePSNaee2c1a1-d848-4c3b-8c6d-8a4f6ce94c2810
198045nortriptyline 10 MG Oral CapsuleSCDaee2c1a1-d848-4c3b-8c6d-8a4f6ce94c2810
317136nortriptyline 25 MG Oral CapsuleSCDaee2c1a1-d848-4c3b-8c6d-8a4f6ce94c2810
198046nortriptyline 50 MG Oral CapsuleSCDaee2c1a1-d848-4c3b-8c6d-8a4f6ce94c2810
198047nortriptyline 75 MG Oral CapsuleSCDaee2c1a1-d848-4c3b-8c6d-8a4f6ce94c2810
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYaee2c1a1-d848-4c3b-8c6d-8a4f6ce94c2810
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYaee2c1a1-d848-4c3b-8c6d-8a4f6ce94c2810
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYaee2c1a1-d848-4c3b-8c6d-8a4f6ce94c2810
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYaee2c1a1-d848-4c3b-8c6d-8a4f6ce94c2810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4004-151672400401100 CAPSULE in 1 BOTTLE (51672-4004-1) 100 capsule2000-05-080000-00-00NoNoCurrent
51672-4004-251672400402500 CAPSULE in 1 BOTTLE (51672-4004-2) 500 capsule2000-05-080000-00-00NoNoCurrent
51672-4004-55167240040590 CAPSULE in 1 BOTTLE (51672-4004-5) 90 capsule2000-05-080000-00-00NoNoCurrent
51672-4004-65167240040630 CAPSULE in 1 BOTTLE (51672-4004-6) 30 capsule2000-05-080000-00-00NoNoCurrent