FDA.reportPublic FDA data

PHENDIMETRAZINE TARTRATE

Product NDC
50090-3988
Requested package NDC
50090-3988-0
11-digit product format
500903988
Labeler code
50090
Product ID
50090-3988_bfb5ef35-3ec7-4ac1-accb-cf885b61681e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENDIMETRAZINE TARTRATE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA018074
Marketing category
NDA
Marketing start
2018-07-01
Marketing end
0000-00-00
Substance
PHENDIMETRAZINE TARTRATE
Active strength
105 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
2022-12-31
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 packagepackage50090-398850090-3988-0DDiscontinued by firm2026-07-31

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
N018074-001PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE105MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS, Approved before 1982

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 22:54:322026-06N018074-001PHENDIMETRAZINE TARTRATE105MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS, Approved before 1982a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEAcertis Pharmaceuticals, LLC162140d3-b833-4633-9759-95821a46a6902025-12-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 018074
application number: NDA018074

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3988-02023-02-06C16284748780-1f386c649-a049-0266-e053-dadaa90a7c1aPhendimetrazine Tartrate Extended-Release Capsules CIII
50090-3988-12023-02-06C16284748780-1f386c649-a049-0266-e053-dadaa90a7c1aPhendimetrazine Tartrate Extended-Release Capsules CIII
50090-3988-02023-01-30C16284748780-1f386c649-a049-0266-e053-dadaa90a7c1aPhendimetrazine Tartrate Extended-Release Capsules CIII
50090-3988-12023-01-30C16284748780-1f386c649-a049-0266-e053-dadaa90a7c1aPhendimetrazine Tartrate Extended-Release Capsules CIII

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3988-1EA - Each50090-3988b2351d93-b732-4389-ab8f-6e50eaccd4ff12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3988PHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]7Legacy NDC20230208_0b489f1a-b49b-4218-a863-71c5c7082bd6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3988-05009039880014 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3988-0) 2018-12-180000-00-00NoNoCurrent