Tranylcypromine

Product NDC
70954-538
11-digit product format
709540538
Labeler code
70954
Product ID
70954-538_8ab1c887-76fb-44ca-9999-4eefd3778cfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranylcypromine
Dosage form
TABLET
Route
ORAL
Labeler
Novitium Pharma LLC
Application
ANDA206856
Marketing category
ANDA
Marketing start
2021-06-06
Substance
TRANYLCYPROMINE SULFATE
Active strength
10 mg/1
Pharmacologic classes
Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tranylcypromine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRANYLCYPROMINE SULFATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7ZAT6ES870
Rxcui313447

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5d23806-15ec-bf11-70d3-a53de2b06bf6Product name320230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-538-10Tranylcypromine100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-538TRANYLCYPROMINE TABLET [NOVITIUM PHARMA LLC]1Current NDC, Legacy NDC, 1 package rows20210622_8ab1c887-76fb-44ca-9999-4eefd3778cfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313447tranylcypromine sulfate 10 MG Oral TabletPSNdf892a65-52e4-8eb2-e053-2a95a90aa25f3
313447tranylcypromine 10 MG Oral TabletSCDdf892a65-52e4-8eb2-e053-2a95a90aa25f3
313447tranylcypromine (as tranylcypromine sulfate) 10 MG Oral TabletSYdf892a65-52e4-8eb2-e053-2a95a90aa25f3
313447tranylcypromine sulfate 10 MG Oral TabletPSN8ab1c887-76fb-44ca-9999-4eefd3778cfc1
313447tranylcypromine 10 MG Oral TabletSCD8ab1c887-76fb-44ca-9999-4eefd3778cfc1
313447tranylcypromine (as tranylcypromine sulfate) 10 MG Oral TabletSY8ab1c887-76fb-44ca-9999-4eefd3778cfc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-538-1070954053810100 TABLET in 1 BOTTLE (70954-538-10) 100 tablet2021-06-060000-00-00NoNoCurrent