FDA.reportPublic FDA data

Phendimetrazine Tartrate

Product NDC
63629-7266
11-digit product format
636297266
Labeler code
63629
Product ID
63629-7266_2931767b-22b5-4d1d-9f57-00b49adb8995
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2021-12-31
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 productproduct63629-7266DDiscontinued by firm2026-07-31
excluded packagepackage63629-726663629-7266-0DDiscontinued by firm2026-07-31
excluded packagepackage63629-726663629-7266-1DDiscontinued by firm2026-07-31
excluded packagepackage63629-726663629-7266-2DDiscontinued by firm2026-07-31
excluded packagepackage63629-726663629-7266-3DDiscontinued by firm2026-07-31
excluded packagepackage63629-726663629-7266-4DDiscontinued by firm2026-07-31
excluded packagepackage63629-726663629-7266-5DDiscontinued by firm2026-07-31
excluded packagepackage63629-726663629-7266-6DDiscontinued by firm2026-07-31
excluded packagepackage63629-726663629-7266-7DDiscontinued by firm2026-07-31
excluded packagepackage63629-726663629-7266-8DDiscontinued by firm2026-07-31
excluded packagepackage63629-726663629-7266-9DDiscontinued by firm2026-07-31

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7266-12020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-22020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-32020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-42020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-52020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-62020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-72020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-82020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-92020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-12020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-22020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-32020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-42020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-52020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-62020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-72020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-82020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-92020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7266-1EA - Each63629-726649811e41-3600-4a4c-bd4e-ccc066166d6f12019-08-06
63629-7266-2EA - Each63629-7266710f10de-c923-4059-9bcb-80200e4ce6b412019-08-06
63629-7266-3EA - Each63629-7266f65189c2-a576-4203-b4fd-53171781c4ca12019-08-06
63629-7266-4EA - Each63629-72665b0bca51-5a5a-4a9c-aa92-84581960fbd112019-08-06
63629-7266-5EA - Each63629-72667651a98c-7099-4af0-928e-ef57f88565e612019-08-06
63629-7266-6EA - Each63629-7266a0b9aae3-7704-4863-90b5-ade584045dc512019-08-06
63629-7266-7EA - Each63629-7266a69049ba-255f-42e9-a7af-89c5b048ba8e12019-08-06
63629-7266-8EA - Each63629-7266b3c227aa-4441-4487-80c3-43a159f1e3ed12019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7266-063629726600120 TABLET in 1 BOTTLE (63629-7266-0) 120 tablet2017-04-250000-00-00NoNoCurrent
63629-7266-16362972660130 TABLET in 1 BOTTLE (63629-7266-1) 30 tablet2017-04-250000-00-00NoNoCurrent
63629-7266-26362972660290 TABLET in 1 BOTTLE (63629-7266-2) 90 tablet2017-04-250000-00-00NoNoCurrent
63629-7266-36362972660315 TABLET in 1 BOTTLE (63629-7266-3) 15 tablet2017-04-250000-00-00NoNoCurrent
63629-7266-46362972660460 TABLET in 1 BOTTLE (63629-7266-4) 60 tablet2017-04-250000-00-00NoNoCurrent
63629-7266-5636297266057 TABLET in 1 BOTTLE (63629-7266-5) 7 tablet2017-04-250000-00-00NoNoCurrent
63629-7266-66362972660621 TABLET in 1 BOTTLE (63629-7266-6) 21 tablet2017-04-250000-00-00NoNoCurrent
63629-7266-76362972660742 TABLET in 1 BOTTLE (63629-7266-7) 42 tablet2017-04-250000-00-00NoNoCurrent
63629-7266-863629726608100 TABLET in 1 BOTTLE (63629-7266-8) 100 tablet2017-04-250000-00-00NoNoCurrent
63629-7266-96362972660928 TABLET in 1 BOTTLE (63629-7266-9) 28 tablet2006-11-100000-00-00NoNoCurrent