Protriptyline Hydrochloride

Product NDC
0054-0211
11-digit product format
000540211
Labeler code
0054
Product ID
0054-0211_5e20e02b-8764-41bf-acd3-aecd03c2dfc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Protriptyline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA078913
Marketing category
ANDA
Marketing start
2008-09-16
Marketing end
0000-00-00
Substance
PROTRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
827db2a4-2747-4bc2-b3aa-fde23307b13cProduct name220201013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0211-25EA - Each0054-02112e314746-9e68-48f1-bf09-e81b479225f312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROTRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT44665V00O8PROTRIPTYLINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]3
PROTRIPTYLINEACTIVE MOIETY4NDU154T12PROTRIPTYLINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPROTRIPTYLINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROTRIPTYLINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROTRIPTYLINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROTRIPTYLINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0211PROTRIPTYLINE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.]6Legacy NDC20250403_700abc58-9362-4ef5-9d7a-dd3c4d364d0a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0211-2500054021125100 TABLET in 1 BOTTLE (0054-0211-25) 100 tablet2008-09-160000-00-00NoNoCurrent