FDA.reportPublic FDA data

Phenelzine Sulfate

Product NDC
40032-360
11-digit product format
400320360
Labeler code
40032
Product ID
40032-360_c3334c58-bba0-44a7-8d65-51ac865dd21d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenelzine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA200181
Marketing category
ANDA
Marketing start
2011-02-14
Marketing end
0000-00-00
Substance
PHENELZINE SULFATE
Active strength
15 mg/1
Pharmacologic classes
Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
0cd971f4-e45f-4585-82c3-177043058d35Product name120170614
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40032-360-212020-01-31C16284748780-19d75b9d0-0697-f424-e053-dadaa90a57cePHENELZINE SULFATE TABLETS, USP Novel Laboratories, Inc. Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-360-21Phenelzine Sulfate60 in 1 BOTTLETABLET602

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENELZINE SULFATEACTIVE INGREDIENT2681D7P965PHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2
PHENELZINEACTIVE MOIETYO408N561GFPHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36APHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PPHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-360PHENELZINE SULFATE TABLET [NOVEL LABORATORIES, INC.]2Legacy NDC, 1 package rows20141008_b7ec6ae7-3d76-42aa-9d8a-fc3e187769b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312347phenelzine sulfate 15 MG Oral TabletPSNb7ec6ae7-3d76-42aa-9d8a-fc3e187769b52
312347phenelzine 15 MG Oral TabletSCDb7ec6ae7-3d76-42aa-9d8a-fc3e187769b52
312347phenelzine (as phenelzine sulfate) 15 MG Oral TabletSYb7ec6ae7-3d76-42aa-9d8a-fc3e187769b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
40032-360-214003203602160 in 1 BOTTLEHistorical