FDA.reportPublic FDA data

PHENDIMETRAZINE TARTRATE

Product NDC
52959-886
11-digit product format
529590886
Labeler code
52959
Product ID
52959-886_76692cfd-6252-450d-e053-2a91aa0a742f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENDIMETRAZINE TARTRATE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
NDA018074
Marketing category
NDA
Marketing start
2007-06-19
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
2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-886IInactivated by FDA2026-07-31
excluded packagepackage52959-88652959-886-07IInactivated by FDA2026-07-31
excluded packagepackage52959-88652959-886-14IInactivated by FDA2026-07-31
excluded packagepackage52959-88652959-886-30IInactivated 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
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

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
52959-886-072020-01-31C16284748780-19d75b9d1-13fe-f424-e053-dadaa90a57ce0282/0886 PHENDIMETRAZINE
52959-886-142020-01-31C16284748780-19d75b9d1-13fe-f424-e053-dadaa90a57ce0282/0886 PHENDIMETRAZINE
52959-886-302020-01-31C16284748780-19d75b9d1-13fe-f424-e053-dadaa90a57ce0282/0886 PHENDIMETRAZINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-886-07PHENDIMETRAZINE TARTRATEER7 in 1 BOTTLECAPSULE, EXTENDED RELEASE72
52959-886-14PHENDIMETRAZINE TARTRATEER14 in 1 BOTTLECAPSULE, EXTENDED RELEASE142
52959-886-30PHENDIMETRAZINE TARTRATEER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-886-07EA - Each52959-88632bf2c4e-30e2-4ecd-8146-cd4723d7898212018-10-11
52959-886-30EA - Each52959-886908ee1db-4399-4590-9bac-3aaa4556a45c12018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1
PHENDIMETRAZINEACTIVE MOIETYAB2794W8KVPHENDIMETRAZINE TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENDIMETRAZINE TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MPHENDIMETRAZINE TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENDIMETRAZINE TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENDIMETRAZINE TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENDIMETRAZINE TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PHENDIMETRAZINE TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-886PHENDIMETRAZINE TARTRATE ER (PHENDIMETRAZINE TARTRATE) CAPSULE, EXTENDED RELEASE PHENDIMETRAZINE TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 3 package rows20180922_49b13acc-c7a9-4f7c-bcc2-2c73fcedab52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979543phendimetrazine tartrate 105 MG 24HR Extended Release Oral CapsulePSN49b13acc-c7a9-4f7c-bcc2-2c73fcedab522
979549phendimetrazine tartrate 35 MG Oral TabletPSN49b13acc-c7a9-4f7c-bcc2-2c73fcedab522
97954324 HR phendimetrazine tartrate 105 MG Extended Release Oral CapsuleSCD49b13acc-c7a9-4f7c-bcc2-2c73fcedab522
979549phendimetrazine tartrate 35 MG Oral TabletSCD49b13acc-c7a9-4f7c-bcc2-2c73fcedab522
979543phendimetrazine 105 MG 24 HR Extended Release Oral CapsuleSY49b13acc-c7a9-4f7c-bcc2-2c73fcedab522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-886-07529590886077 in 1 BOTTLEHistorical
52959-886-145295908861414 in 1 BOTTLEHistorical
52959-886-305295908863030 in 1 BOTTLEHistorical