Nortriptyline Hydrochloride

Product NDC
68788-8721
11-digit product format
687888721
Labeler code
68788
Product ID
68788-8721_aab4a02d-0e0a-4272-b79d-38301b2115eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA073556
Marketing category
ANDA
Marketing start
2024-08-09
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui317136

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8721-1Nortriptyline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1002
68788-8721-3Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE302
68788-8721-6Nortriptyline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE602
68788-8721-9Nortriptyline Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8721-1EA - Each68788-8721702f3665-440e-40ff-8480-9d82cf52dcd912024-09-09
68788-8721-3EA - Each68788-8721f983249f-f250-4a3e-9840-26a47c355fa912024-09-09
68788-8721-6EA - Each68788-8721d1cf20cc-54ce-497d-ace9-039a45bc57f912024-09-09
68788-8721-9EA - Each68788-872141312255-f294-4b65-be71-82f5e0d7cc2a12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8721NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20240810_f684e9c8-eca7-4e27-872d-c0adea19de9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSNf684e9c8-eca7-4e27-872d-c0adea19de9a2
317136nortriptyline 25 MG Oral CapsuleSCDf684e9c8-eca7-4e27-872d-c0adea19de9a2
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYf684e9c8-eca7-4e27-872d-c0adea19de9a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8721-168788872101100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8721-1) 100 capsule2024-08-09NoNoHistorical
68788-8721-36878887210330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8721-3) 30 capsule2024-08-09NoNoHistorical
68788-8721-66878887210660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8721-6) 60 capsule2024-08-09NoNoHistorical
68788-8721-96878887210990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8721-9) 90 capsule2024-08-09NoNoHistorical