Nortriptyline Hydrochloride

Product NDC
68071-2327
11-digit product format
680712327
Labeler code
68071
Product ID
68071-2327_b85769ba-8149-1adb-e053-2a95a90a0556
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA073556
Marketing category
ANDA
Marketing start
2019-12-12
Marketing end
0000-00-00
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2327-32023-01-30C16284748780-1f386c64a-2c63-0266-e053-dadaa90a7c1aNortriptyline Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2327-3Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2327NORTRIPTYLINE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20210108_b857696e-5227-1a15-e053-2a95a90a1a1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNb857696e-5227-1a15-e053-2a95a90a1a1b1
198045nortriptyline 10 MG Oral CapsuleSCDb857696e-5227-1a15-e053-2a95a90a1a1b1
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYb857696e-5227-1a15-e053-2a95a90a1a1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2327-36807123270330 CAPSULE in 1 BOTTLE, PLASTIC (68071-2327-3) 30 capsule2021-01-070000-00-00NoNoCurrent