FDA.reportPublic FDA data

Phendimetrazine Tartrate

Product NDC
63629-7266
Requested package NDC
63629-7266-8
11-digit product format
636297266
Labeler code
63629
Product ID
63629-7266_2931767b-22b5-4d1d-9f57-00b49adb8995
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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 packagepackage63629-726663629-7266-8DDiscontinued 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7266-12020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-22020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-32020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-42020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-52020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-62020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-72020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-82020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-92020-05-22C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-12020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-22020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-32020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-42020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-52020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-62020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-72020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-82020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg
63629-7266-92020-01-31C16284748780-19d75b9d0-aaf8-f424-e053-dadaa90a57cePhendimetrazine Tartrate Tablets USP, 35 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7266-1EA - Each63629-726649811e41-3600-4a4c-bd4e-ccc066166d6f12019-08-06
63629-7266-2EA - Each63629-7266710f10de-c923-4059-9bcb-80200e4ce6b412019-08-06
63629-7266-3EA - Each63629-7266f65189c2-a576-4203-b4fd-53171781c4ca12019-08-06
63629-7266-4EA - Each63629-72665b0bca51-5a5a-4a9c-aa92-84581960fbd112019-08-06
63629-7266-5EA - Each63629-72667651a98c-7099-4af0-928e-ef57f88565e612019-08-06
63629-7266-6EA - Each63629-7266a0b9aae3-7704-4863-90b5-ade584045dc512019-08-06
63629-7266-7EA - Each63629-7266a69049ba-255f-42e9-a7af-89c5b048ba8e12019-08-06
63629-7266-8EA - Each63629-7266b3c227aa-4441-4487-80c3-43a159f1e3ed12019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7266-863629726608100 TABLET in 1 BOTTLE (63629-7266-8) 100 tablet2017-04-250000-00-00NoNoCurrent