Phendimetrazine Tartrate

Product NDC
63629-3051
Requested package NDC
63629-3051-8
11-digit product format
636293051
Labeler code
63629
Product ID
63629-3051_73ea77b3-ac38-4888-9e19-74b2f5e6887f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA018074
Marketing category
NDA
Marketing start
1977-09-06
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
2021-12-31
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 packagepackage63629-305163629-3051-8DDiscontinued 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
63629-3051-12020-10-16C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-22020-10-16C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-32020-10-16C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-42020-10-16C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-52020-10-16C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-62020-10-16C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-72020-10-16C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-82020-10-16C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-92020-10-16C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-12020-01-31C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-22020-01-31C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-32020-01-31C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-42020-01-31C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-52020-01-31C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-62020-01-31C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-72020-01-31C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-82020-01-31C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII
63629-3051-92020-01-31C16284748780-19d75b9d0-0b77-f424-e053-dadaa90a57cePhendimetrazine Tartrate Extended-release Capsules CIII

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3051-1EA - Each63629-3051ebf32814-e68c-4739-9761-7d3b1b8d9ab112012-07-24
63629-3051-2EA - Each63629-3051266a08d6-0bde-4868-9c80-711b4643ccee12012-07-24
63629-3051-3EA - Each63629-3051d9a0b56b-7719-46de-aea1-487276eeaed112012-07-24
63629-3051-4EA - Each63629-305143b12086-56b7-4abc-939b-c77db07985c312012-07-24
63629-3051-5EA - Each63629-3051ff9fe654-4140-4d12-969d-68b06fdc041d12012-07-24

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-3051-86362930510821 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-3051-8) 2006-01-300000-00-00NoNoCurrent