Home NDC 17224-501 PHENDIMETRAZINE TARTRATE
Product NDC 17224-501
11-digit product format 172240501
Labeler code 17224
Product ID 17224-501_9edd68ed-0632-412f-b422-4c0066a87b3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PHENDIMETRAZINE TARTRATE
Dosage form TABLET
Route ORAL
Labeler CALVIN, SCOTT AND COMPANY, INCORPORATED
Application ANDA085588
Marketing category ANDA
Marketing start 2018-07-01
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 Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 17224-501 I Inactivated by FDA 2026-07-31 excluded package package 17224-501 17224-501-10 I Inactivated by FDA 2026-07-31
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A085588-001 PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982
Therapeutic equivalence codes# Application-product, TE code table Application-product TE code A085588-001 AA
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.
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17224-501-10 PHENDIMETRAZINE TARTRATE 28 in 1 BOTTLE TABLET 28 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17224-501 PHENDIMETRAZINE TARTRATE TABLET [CALVIN, SCOTT AND COMPANY, INCORPORATED] 2 Legacy NDC, 1 package rows 20191120_577d69c4-35ae-4c2a-b707-b5b353c91b35.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 17224-501-10 17224050110 28 in 1 BOTTLE Historical