Nortriptyline Hydrochloride

Product NDC
53217-254
11-digit product format
532170254
Labeler code
53217
Product ID
53217-254_59579982-ea54-48d8-91a1-a49e65f27a98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075520
Marketing category
ANDA
Marketing start
2000-05-08
Marketing end
0000-00-00
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-254-02Nortriptyline Hydrochloride120 in 1 BOTTLECAPSULE1206
53217-254-30Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE306
53217-254-60Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE606
53217-254-90Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-254NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]6Legacy NDC, 4 package rows20161104_1b38c215-2a7d-4ac7-a19f-553a43ecd6a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSN1b38c215-2a7d-4ac7-a19f-553a43ecd6a96
317136nortriptyline 25 MG Oral CapsuleSCD1b38c215-2a7d-4ac7-a19f-553a43ecd6a96
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY1b38c215-2a7d-4ac7-a19f-553a43ecd6a96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-254-0253217025402120 in 1 BOTTLEHistorical
53217-254-305321702543030 in 1 BOTTLEHistorical
53217-254-605321702546060 in 1 BOTTLEHistorical
53217-254-905321702549090 in 1 BOTTLEHistorical