FDA.reportPublic FDA data

NORTRIPTYLINE HYDROCHLORIDE

Product NDC
61919-171
11-digit product format
619190171
Labeler code
61919
Product ID
61919-171_48468ca6-013d-3ee8-e063-6294a90a61c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NORTRIPTYLINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
ANDA074132
Marketing category
ANDA
Marketing start
2015-01-01
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NORTRIPTYLINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198045, 317136

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-171-602025-08-06C16284748780-19d75b9d0-7a32-f424-e053-dadaa90a57ceNORTRIPTYLINE HYDROCHLORIDE
61919-171-602025-08-06C16284748780-19d75b9d0-7a32-f424-e053-dadaa90a57ceNORTRIPTYLINE HYDROCHLORIDE
61919-171-602020-01-31C16284748780-19d75b9d0-7a32-f424-e053-dadaa90a57ceNORTRIPTYLINE HYDROCHLORIDE
61919-171-602020-01-31C16284748780-19d75b9d0-7a32-f424-e053-dadaa90a57ceNORTRIPTYLINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-171-30NORTRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE305
61919-171-60NORTRIPTYLINE HYDROCHLORIDE60 in 1 BOTTLECAPSULE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-171-30EA - Each61919-171d541b440-24c2-4fd2-9673-b4207aab70c712014-05-02
61919-171-60EA - Each61919-171f9cd5921-d642-46d5-b30e-e152ad3c6ae212014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
61919-171NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]2Current NDC, Legacy NDC, 2 package rows20150807_017f7717-e160-4142-9a5a-1a2bd9776707.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61919-171-306191901713030 CAPSULE in 1 BOTTLE (61919-171-30) 30 capsule2015-01-01NoNoHistorical
61919-171-606191901716060 BOTTLE in 1 BOTTLE (61919-171-60) / 30 CAPSULE in 1 BOTTLE (61919-171-30) 60 bottle2025-08-06NoNoHistorical