Nortriptyline Hydrochloride

Product NDC
43063-722
11-digit product format
430630722
Labeler code
43063
Product ID
43063-722_414b1374-fc77-1888-e063-6394a90ad253
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA073556
Marketing category
ANDA
Marketing start
2016-06-01
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
43063-722-30Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-722-30EA - Each43063-72234908b55-4ac2-4cc9-b873-118a7a092f7112016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-722NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 1 package rows20241016_ba4edb34-82ac-4c98-8abd-fd6176838c78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSNba4edb34-82ac-4c98-8abd-fd6176838c7816
317136nortriptyline 25 MG Oral CapsuleSCDba4edb34-82ac-4c98-8abd-fd6176838c7816
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYba4edb34-82ac-4c98-8abd-fd6176838c7816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-722-304306307223030 CAPSULE in 1 BOTTLE, PLASTIC (43063-722-30) 30 capsule2016-10-270000-00-00NoNoCurrent