FDA.reportPublic FDA data

Tranylcypromine

Product NDC
43547-655
11-digit product format
435470655
Labeler code
43547
Product ID
43547-655_df2e24b3-c948-4f36-863c-589296f651fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRANYLCYPROMINE
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA213503
Marketing category
ANDA
Marketing start
2022-12-10
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e5d23806-15ec-bf11-70d3-a53de2b06bf6Product name320230314
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
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
43547-655-102024-12-20C16284748780-11030e365-62bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRANYLCYPROMINE TABLETS safely and effectively. See full prescribing information for TRANYLCYPROMINE TABLETS. TRANYLCYPROMINE tablets, for oral use Initial U.S. Approval: 1961
43547-655-102024-01-30C16284748780-11030e365-62bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRANYLCYPROMINE TABLETS safely and effectively. See full prescribing information for TRANYLCYPROMINE TABLETS. TRANYLCYPROMINE tablets, for oral use Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-655-10Tranylcypromine100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-655-10EA - Each43547-655fc629c55-d1a8-4075-abd4-d6028aa7cde812023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-655TRANYLCYPROMINE TABLET [SOLCO HEALTHCARE US, LLC]3Current NDC, Legacy NDC, 1 package rows20241225_3c14a558-2df4-4d93-97dd-640dec6ee785.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313447tranylcypromine sulfate 10 MG Oral TabletPSN3c14a558-2df4-4d93-97dd-640dec6ee7853
313447tranylcypromine 10 MG Oral TabletSCD3c14a558-2df4-4d93-97dd-640dec6ee7853
313447tranylcypromine (as tranylcypromine sulfate) 10 MG Oral TabletSY3c14a558-2df4-4d93-97dd-640dec6ee7853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-655-1043547065510100 TABLET in 1 BOTTLE (43547-655-10) 100 tablet2022-12-100000-00-00NoNoCurrent