FDA.reportPublic FDA data

PHENDIMETRAZINE TARTRATE

Product NDC
43063-892
Requested package NDC
43063-892-30
11-digit product format
430630892
Labeler code
43063
Product ID
43063-892_d0625fc9-2170-5d63-e053-2995a90abfaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENDIMETRAZINE TARTRATE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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 packagepackage43063-89243063-892-30DDiscontinued 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-892-14EA - Each43063-892937b91da-6085-4596-ae6d-d26a52b7784112018-10-11
43063-892-30EA - Each43063-89239bf2764-89a9-4fab-9f59-071de9549ab712018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-892-304306308923030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-892-30) 2018-09-200000-00-00NoNoCurrent