FDA.reportPublic FDA data

Phendimetrazine Tartrate

Product NDC
50090-2592
Requested package NDC
50090-2592-1
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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

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

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A085588-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAAApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A085588-001AA1a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEBryant Ranch Prepack75f6c4bc-ed72-498a-822c-ecc2a13df9582026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085588
application number: ANDA085588
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEVirtus Pharmaceuticals, LLCcc9a0cd2-6fb9-47ab-8e39-146d2fa361c22025-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085588
application number: ANDA085588
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEBryant Ranch Prepack137e5fcd-9536-4fb9-9885-5dfd1127c35a2025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085588
application number: ANDA085588

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
50090-2592-15009025920160 TABLET in 1 BOTTLE, PLASTIC (50090-2592-1) 60 tablet2014-11-280000-00-00NoNoCurrent