FDA.reportPublic FDA data

Phendimetrazine Tartrate

Product NDC
71335-0324
11-digit product format
713350324
Labeler code
71335
Product ID
71335-0324_e2bbffcf-c0cc-4dbc-b5e4-cdc5fd7cd0c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091042
Marketing category
ANDA
Marketing start
2010-09-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phendimetrazine Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENDIMETRAZINE TARTRATE35 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6985IP0T80
Rxcui979549

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
71525015-bcb9-5864-7749-4b5f528a6b6aProduct name220180419
977c925f-5460-67b1-e843-25a0ba370df1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0324-0Phendimetrazine Tartrate120 in 1 BOTTLETABLET12013
71335-0324-1Phendimetrazine Tartrate30 in 1 BOTTLETABLET3013
71335-0324-2Phendimetrazine Tartrate90 in 1 BOTTLETABLET9013
71335-0324-3Phendimetrazine Tartrate15 in 1 BOTTLETABLET1513
71335-0324-4Phendimetrazine Tartrate60 in 1 BOTTLETABLET6013
71335-0324-5Phendimetrazine Tartrate7 in 1 BOTTLETABLET713
71335-0324-6Phendimetrazine Tartrate21 in 1 BOTTLETABLET2113
71335-0324-7Phendimetrazine Tartrate42 in 1 BOTTLETABLET4213
71335-0324-8Phendimetrazine Tartrate100 in 1 BOTTLETABLET10013
71335-0324-9Phendimetrazine Tartrate28 in 1 BOTTLETABLET2813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0324-0EA - Each71335-032423e95b5b-b685-4125-866a-6856e4384b8312025-08-11
71335-0324-1EA - Each71335-032426c4b66b-205e-4682-a904-18ef957951ff12019-08-06
71335-0324-2EA - Each71335-0324a5039020-d9f9-465e-b7fa-0241d0b07bbd12019-08-06
71335-0324-3EA - Each71335-0324c7e309e8-89c0-4852-994b-8d9e25437f1512019-08-06
71335-0324-4EA - Each71335-0324a8535c77-f03e-4acc-ba77-226468fe5d0612019-08-06
71335-0324-5EA - Each71335-0324304ba902-6fcf-4c60-87d5-bd1f245f15b812019-08-06
71335-0324-6EA - Each71335-0324e4e75ff7-0676-4546-a1cb-696859526bad12019-08-06
71335-0324-7EA - Each71335-03246f7bae0b-6a84-4028-854a-4ce95815c0af12019-08-06
71335-0324-8EA - Each71335-0324278d4c5f-c7bc-4ec0-9240-96aab38e056612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0324PHENDIMETRAZINE TARTRATE TABLET [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 10 package rows20240809_1c2370fd-6b40-48dc-a42d-2488041d5b37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979549phendimetrazine tartrate 35 MG Oral TabletPSN1c2370fd-6b40-48dc-a42d-2488041d5b3713
979549phendimetrazine tartrate 35 MG Oral TabletSCD1c2370fd-6b40-48dc-a42d-2488041d5b3713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0324-071335032400120 TABLET in 1 BOTTLE (71335-0324-0) 120 tablet2017-09-290000-00-00NoNoCurrent
71335-0324-17133503240130 TABLET in 1 BOTTLE (71335-0324-1) 30 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-27133503240290 TABLET in 1 BOTTLE (71335-0324-2) 90 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-37133503240315 TABLET in 1 BOTTLE (71335-0324-3) 15 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-47133503240460 TABLET in 1 BOTTLE (71335-0324-4) 60 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-5713350324057 TABLET in 1 BOTTLE (71335-0324-5) 7 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-67133503240621 TABLET in 1 BOTTLE (71335-0324-6) 21 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-77133503240742 TABLET in 1 BOTTLE (71335-0324-7) 42 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-871335032408100 TABLET in 1 BOTTLE (71335-0324-8) 100 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-97133503240928 TABLET in 1 BOTTLE (71335-0324-9) 28 tablet2011-04-260000-00-00NoNoCurrent