Nortriptyline Hydrochloride

Product NDC
63187-798
11-digit product format
631870798
Labeler code
63187
Product ID
63187-798_4aa4c04f-3f5f-49a4-b1a6-eba6e09a588b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075520
Marketing category
ANDA
Marketing start
2000-05-08
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198046

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
63187-798-30Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE304
63187-798-60Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE604
63187-798-90Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-798NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220616_c5b1ef5e-9681-426a-abf6-60d9c28d92a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198046nortriptyline HCl 50 MG Oral CapsulePSNc5b1ef5e-9681-426a-abf6-60d9c28d92a04
198046nortriptyline 50 MG Oral CapsuleSCDc5b1ef5e-9681-426a-abf6-60d9c28d92a04
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYc5b1ef5e-9681-426a-abf6-60d9c28d92a04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-798-306318707983030 CAPSULE in 1 BOTTLE (63187-798-30) 30 capsule2017-01-010000-00-00NoNoCurrent
63187-798-606318707986060 CAPSULE in 1 BOTTLE (63187-798-60) 60 capsule2017-01-010000-00-00NoNoCurrent
63187-798-906318707989090 CAPSULE in 1 BOTTLE (63187-798-90) 90 capsule2017-01-010000-00-00NoNoCurrent