Nortriptyline Hydrochloride

Product NDC
71335-0065
11-digit product format
713350065
Labeler code
71335
Product ID
71335-0065_44dcf81d-9d13-4631-9611-3394084f8c05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074132
Marketing category
ANDA
Marketing start
1995-04-05
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
Rxcui198047

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0065-1Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE306
71335-0065-2Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE606
71335-0065-3Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE906
71335-0065-4Nortriptyline Hydrochloride28 in 1 BOTTLECAPSULE286

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0065-1EA - Each71335-00654f3947f0-ad1f-40e1-b864-a6c68e52974812018-03-08
71335-0065-2EA - Each71335-0065aaad9f1a-1837-4c36-8f1d-f32ff138569412018-03-08
71335-0065-3EA - Each71335-0065cc762333-cdb5-4979-a5be-684dd4f2be2912018-03-08
71335-0065-4EA - Each71335-0065dbea88eb-50a5-4f10-83aa-77e4c2b88fb512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0065NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 4 package rows20220122_962f3f54-0556-4509-a231-ca62cb01bec8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198047nortriptyline HCl 75 MG Oral CapsulePSN962f3f54-0556-4509-a231-ca62cb01bec86
198047nortriptyline 75 MG Oral CapsuleSCD962f3f54-0556-4509-a231-ca62cb01bec86
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSY962f3f54-0556-4509-a231-ca62cb01bec86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0065-17133500650130 CAPSULE in 1 BOTTLE (71335-0065-1) 30 capsule2018-07-270000-00-00NoNoCurrent
71335-0065-27133500650260 CAPSULE in 1 BOTTLE (71335-0065-2) 60 capsule2021-12-270000-00-00NoNoCurrent
71335-0065-37133500650390 CAPSULE in 1 BOTTLE (71335-0065-3) 90 capsule2021-12-270000-00-00NoNoCurrent
71335-0065-47133500650428 CAPSULE in 1 BOTTLE (71335-0065-4) 28 capsule2021-12-270000-00-00NoNoCurrent