Phendimetrazine Tartrate

Product NDC
63629-1604
11-digit product format
636291604
Labeler code
63629
Product ID
63629-1604_281377de-81c3-4fec-96e9-7b426190c3f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
bryant ranch prepack
Application
ANDA085588
Marketing category
ANDA
Marketing start
2009-06-01
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
E
Listing certified through
2017-12-31
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 productproduct63629-1604DDiscontinued by firm2026-07-31
excluded packagepackage63629-160463629-1604-0DDiscontinued by firm2026-07-31
excluded packagepackage63629-160463629-1604-1DDiscontinued by firm2026-07-31
excluded packagepackage63629-160463629-1604-2DDiscontinued by firm2026-07-31
excluded packagepackage63629-160463629-1604-3DDiscontinued by firm2026-07-31
excluded packagepackage63629-160463629-1604-4DDiscontinued by firm2026-07-31
excluded packagepackage63629-160463629-1604-5DDiscontinued by firm2026-07-31
excluded packagepackage63629-160463629-1604-6DDiscontinued by firm2026-07-31
excluded packagepackage63629-160463629-1604-7DDiscontinued by firm2026-07-31
excluded packagepackage63629-160463629-1604-8DDiscontinued by firm2026-07-31
excluded packagepackage63629-160463629-1604-9DDiscontinued 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
63629-1604-02021-07-01C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-12021-07-01C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-22021-07-01C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-32021-07-01C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-42021-07-01C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-52021-07-01C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-62021-07-01C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-72021-07-01C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-82021-07-01C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-92021-07-01C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-02019-10-21C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-12019-10-21C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-22019-10-21C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-32019-10-21C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-42019-10-21C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-52019-10-21C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-62019-10-21C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-72019-10-21C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-82019-10-21C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet
63629-1604-92019-10-21C16284748780-1956f9ecf-c4aa-621f-e053-dbdaa90a74adPhendimetrazine Tartrate 35mg Tablet

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1604-1EA - Each63629-16047abbdd02-10e1-4c6f-adb6-b12695d92e7512012-07-24
63629-1604-2EA - Each63629-160427c632d7-44da-4aa6-bb59-f3a02621cc7f12012-07-24
63629-1604-3EA - Each63629-1604f0384a07-42d6-4af9-81bb-d412cb7387b312012-07-24
63629-1604-4EA - Each63629-1604e4ae29dc-227f-40d5-9c21-b5916234463612012-07-24
63629-1604-5EA - Each63629-1604a9ce9d66-e41c-4ab6-b05d-083280f23ce512012-07-24
63629-1604-6EA - Each63629-1604c05c6c1e-f0ad-4694-a5e3-c229dbf1a9ef12012-07-24
63629-1604-7EA - Each63629-160414f5b353-015b-40a9-9181-df90215220c212012-07-24
63629-1604-8EA - Each63629-16043e9a9fc5-44dd-4627-893c-5da52e78558812012-07-24
63629-1604-9EA - Each63629-1604ddcd3f1f-3c1c-4a9f-9e16-52021917a06012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE TABLET [BRYANT RANCH PREPACK]1
PHENDIMETRAZINEACTIVE MOIETYAB2794W8KVPHENDIMETRAZINE TARTRATE TABLET [BRYANT RANCH PREPACK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENDIMETRAZINE TARTRATE TABLET [BRYANT RANCH PREPACK]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENDIMETRAZINE TARTRATE TABLET [BRYANT RANCH PREPACK]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENDIMETRAZINE TARTRATE TABLET [BRYANT RANCH PREPACK]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPHENDIMETRAZINE TARTRATE TABLET [BRYANT RANCH PREPACK]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHENDIMETRAZINE TARTRATE TABLET [BRYANT RANCH PREPACK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENDIMETRAZINE TARTRATE TABLET [BRYANT RANCH PREPACK]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENDIMETRAZINE TARTRATE TABLET [BRYANT RANCH PREPACK]1