FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
50090-0537
11-digit product format
500900537
Labeler code
50090
Product ID
50090-0537_e05438b4-aaee-4ff7-a51b-1e5f64f08d95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075520
Marketing category
ANDA
Marketing start
2000-05-08
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198045

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0537-02023-02-07C16284748780-1f386c649-ced3-0266-e053-dadaa90a7c1aNortriptyline Hydrochloride Capsules, USP
50090-0537-12023-02-07C16284748780-1f386c649-ced3-0266-e053-dadaa90a7c1aNortriptyline Hydrochloride Capsules, USP
50090-0537-02023-01-30C16284748780-1f386c649-ced3-0266-e053-dadaa90a7c1aNortriptyline Hydrochloride Capsules, USP
50090-0537-12023-01-30C16284748780-1f386c649-ced3-0266-e053-dadaa90a7c1aNortriptyline Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0537-0Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE6016
50090-0537-1Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0537-0EA - Each50090-0537a3239598-a8cd-45bf-9795-647661da460512018-09-05
50090-0537-1EA - Each50090-0537d38a31aa-beb0-4b76-a80e-93bbd7be03a012018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0537NORTRIPTYLINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 2 package rows20240214_53346b9c-40a1-4b5b-8df0-0b393661fb85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSN53346b9c-40a1-4b5b-8df0-0b393661fb8516
198045nortriptyline 10 MG Oral CapsuleSCD53346b9c-40a1-4b5b-8df0-0b393661fb8516
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY53346b9c-40a1-4b5b-8df0-0b393661fb8516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0537-05009005370060 CAPSULE in 1 BOTTLE (50090-0537-0) 60 capsule2016-06-290000-00-00NoNoCurrent
50090-0537-15009005370130 CAPSULE in 1 BOTTLE (50090-0537-1) 30 capsule2016-06-290000-00-00NoNoCurrent