Nortriptyline Hydrochloride

Product NDC
68071-3211
11-digit product format
680713211
Labeler code
68071
Product ID
68071-3211_1da1201b-5eff-2f85-e063-6294a90a969c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA075520
Marketing category
ANDA
Marketing start
2000-05-08
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
68071-3211-1Nortriptyline Hydrochloride120 in 1 BOTTLECAPSULE1204
68071-3211-2Nortriptyline Hydrochloride20 in 1 BOTTLECAPSULE204
68071-3211-3Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE304
68071-3211-5Nortriptyline Hydrochloride45 in 1 BOTTLECAPSULE454
68071-3211-6Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE604
68071-3211-9Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3211NORTRIPTYLINE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 6 package rows20240720_51778813-0ec1-6b4f-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSN51778813-0ec1-6b4f-e054-00144ff8d46c4
317136nortriptyline 25 MG Oral CapsuleSCD51778813-0ec1-6b4f-e054-00144ff8d46c4
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY51778813-0ec1-6b4f-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3211-168071321101120 CAPSULE in 1 BOTTLE (68071-3211-1) 120 capsule2017-06-080000-00-00NoNoCurrent
68071-3211-26807132110220 CAPSULE in 1 BOTTLE (68071-3211-2) 20 capsule2017-06-080000-00-00NoNoCurrent
68071-3211-36807132110330 CAPSULE in 1 BOTTLE (68071-3211-3) 30 capsule2017-06-080000-00-00NoNoCurrent
68071-3211-56807132110545 CAPSULE in 1 BOTTLE (68071-3211-5) 45 capsule2017-06-080000-00-00NoNoCurrent
68071-3211-66807132110660 CAPSULE in 1 BOTTLE (68071-3211-6) 60 capsule2017-06-080000-00-00NoNoCurrent
68071-3211-96807132110990 CAPSULE in 1 BOTTLE (68071-3211-9) 90 capsule2017-06-080000-00-00NoNoCurrent