FDA.reportPublic FDA data

Phendimetrazine Tartrate

Product NDC
50090-2592
11-digit product format
500902592
Labeler code
50090
Product ID
50090-2592_91915a50-683a-4c17-a119-aa7bb58f0900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA085588
Marketing category
ANDA
Marketing start
1977-08-19
Marketing end
0000-00-00
Substance
PHENDIMETRAZINE TARTRATE
Active strength
35 mg/1
Pharmacologic classes
Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-2592IInactivated by FDA2026-07-31
excluded packagepackage50090-259250090-2592-0IInactivated by FDA2026-07-31
excluded packagepackage50090-259250090-2592-1IInactivated by FDA2026-07-31
excluded packagepackage50090-259250090-2592-2IInactivated by FDA2026-07-31
excluded packagepackage50090-259250090-2592-6IInactivated by FDA2026-07-31
excluded packagepackage50090-259250090-2592-9IInactivated by FDA2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085588-001PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE35MGTABLET / ORALAAApproved before 1982

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A085588-001AA

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEBryant Ranch Prepack75f6c4bc-ed72-498a-822c-ecc2a13df9582026-04-01Warnings, Adverse reactionsExact identifier
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEVirtus Pharmaceuticals, LLCcc9a0cd2-6fb9-47ab-8e39-146d2fa361c22025-12-19Warnings, Adverse reactionsExact identifier
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEBryant Ranch Prepack137e5fcd-9536-4fb9-9885-5dfd1127c35a2025-01-30Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Tolerance to the anorectic effect of phendimetrazine develops within a few weeks. When this occurs, its use should be discontinued; the maximum recommended dose should not be exceeded. Use of phendimetrazine tartrate within 14 days following the administration of monoamine oxidase inhibitors may result in a hypertensive crisis. Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system, phendimetrazine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS Cardiovascular: Palpitation, tachycardia, elevated blood pressure. Central Nervous System: Overstimulation, restlessness, insomnia, agitation, flushing, tremor, sweating, dizziness, headache, psychotic state, blurring of vision. Gastrointestinal: Dryness of the mouth, nausea, diarrhea, constipation, stomach pain. Genitourinary: Urinary frequency, dysuria, changes in libido.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
71525015-bcb9-5864-7749-4b5f528a6b6aProduct name220180419
977c925f-5460-67b1-e843-25a0ba370df1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2592-02023-01-30C16284748780-1f386c649-ce53-0266-e053-dadaa90a7c1aPhendimetrazine Tartrate Tablets USP, 35 mg
50090-2592-12023-01-30C16284748780-1f386c649-ce53-0266-e053-dadaa90a7c1aPhendimetrazine Tartrate Tablets USP, 35 mg
50090-2592-22023-01-30C16284748780-1f386c649-ce53-0266-e053-dadaa90a7c1aPhendimetrazine Tartrate Tablets USP, 35 mg
50090-2592-62023-01-30C16284748780-1f386c649-ce53-0266-e053-dadaa90a7c1aPhendimetrazine Tartrate Tablets USP, 35 mg
50090-2592-92023-01-30C16284748780-1f386c649-ce53-0266-e053-dadaa90a7c1aPhendimetrazine Tartrate Tablets USP, 35 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2592-0Phendimetrazine Tartrate30 in 1 BOTTLETABLET3010
50090-2592-1Phendimetrazine Tartrate60 in 1 BOTTLE, PLASTICTABLET6010
50090-2592-2Phendimetrazine Tartrate90 in 1 BOTTLETABLET9010
50090-2592-6Phendimetrazine Tartrate28 in 1 BOTTLETABLET2810
50090-2592-9Phendimetrazine Tartrate112 in 1 BOTTLETABLET11210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2592-1EA - Each50090-2592de60c681-428b-40fb-a0ae-8004c327287e12019-05-02
50090-2592-2EA - Each50090-259291f96785-1d61-4a3a-bec3-61f4d7cdf2ff12019-04-11
50090-2592-6EA - Each50090-259215e245dc-d396-45d1-8ae8-8feea2550ccc12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2592PHENDIMETRAZINE TARTRATE TABLET [A-S MEDICATION SOLUTIONS]10Legacy NDC, 5 package rows20190427_a8802ede-d04e-4d2c-8f1d-fd456a5b5e58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979549phendimetrazine tartrate 35 MG Oral TabletPSNa8802ede-d04e-4d2c-8f1d-fd456a5b5e5810
979549phendimetrazine tartrate 35 MG Oral TabletSCDa8802ede-d04e-4d2c-8f1d-fd456a5b5e5810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2592-05009025920030 TABLET in 1 BOTTLE (50090-2592-0) 30 tablet2016-12-070000-00-00NoNoCurrent
50090-2592-15009025920160 TABLET in 1 BOTTLE, PLASTIC (50090-2592-1) 60 tablet2014-11-280000-00-00NoNoCurrent
50090-2592-25009025920290 TABLET in 1 BOTTLE (50090-2592-2) 90 tablet2017-09-080000-00-00NoNoCurrent
50090-2592-65009025920628 TABLET in 1 BOTTLE (50090-2592-6) 28 tablet2017-08-100000-00-00NoNoCurrent
50090-2592-950090259209112 TABLET in 1 BOTTLE (50090-2592-9) 112 tablet2017-02-030000-00-00NoNoCurrent