Nortriptyline Hydrochloride

Product NDC
63187-809
11-digit product format
631870809
Labeler code
63187
Product ID
63187-809_3bc803bf-606e-4857-a8a6-1a33740d35c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074132
Marketing category
ANDA
Marketing start
1995-04-05
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-809-00Nortriptyline Hydrochloride100 in 1 BOTTLECAPSULE1006
63187-809-30Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE306
63187-809-60Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE606
63187-809-90Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-809-30EA - Each63187-809b672dc84-0a4e-4b34-b4fe-3b8c6a9783b112017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-809NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20241024_2f9fc7a0-163a-4a05-84a7-7999a41ecb1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198047nortriptyline HCl 75 MG Oral CapsulePSN2f9fc7a0-163a-4a05-84a7-7999a41ecb1f6
198047nortriptyline 75 MG Oral CapsuleSCD2f9fc7a0-163a-4a05-84a7-7999a41ecb1f6
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSY2f9fc7a0-163a-4a05-84a7-7999a41ecb1f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-809-0063187080900100 CAPSULE in 1 BOTTLE (63187-809-00) 100 capsule2017-02-010000-00-00NoNoCurrent
63187-809-306318708093030 CAPSULE in 1 BOTTLE (63187-809-30) 30 capsule2017-02-010000-00-00NoNoCurrent
63187-809-606318708096060 CAPSULE in 1 BOTTLE (63187-809-60) 60 capsule2017-02-010000-00-00NoNoCurrent
63187-809-906318708099090 CAPSULE in 1 BOTTLE (63187-809-90) 90 capsule2017-02-010000-00-00NoNoCurrent