Nortriptyline Hydrochloride

Product NDC
71205-254
11-digit product format
712050254
Labeler code
71205
Product ID
71205-254_18b1b661-299a-4df2-bd8d-0053860aab80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074132
Marketing category
ANDA
Marketing start
1995-04-06
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
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-254-30Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE305
71205-254-60Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE605
71205-254-90Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-254NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20241024_e047f990-c374-4f8f-8583-c615f92545e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSNe047f990-c374-4f8f-8583-c615f92545e25
317136nortriptyline 25 MG Oral CapsuleSCDe047f990-c374-4f8f-8583-c615f92545e25
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYe047f990-c374-4f8f-8583-c615f92545e25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-254-307120502543030 CAPSULE in 1 BOTTLE (71205-254-30) 30 capsule2019-04-010000-00-00NoNoCurrent
71205-254-607120502546060 CAPSULE in 1 BOTTLE (71205-254-60) 60 capsule2019-04-010000-00-00NoNoCurrent
71205-254-907120502549090 CAPSULE in 1 BOTTLE (71205-254-90) 90 capsule2019-04-010000-00-00NoNoCurrent