FDA.reportPublic FDA data

Phendimetrazine Tartrate

Product NDC
71335-0074
11-digit product format
713350074
Labeler code
71335
Product ID
71335-0074_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
71335-0074-0Phendimetrazine Tartrate120 in 1 BOTTLETABLET12013
71335-0074-1Phendimetrazine Tartrate30 in 1 BOTTLETABLET3013
71335-0074-2Phendimetrazine Tartrate135 in 1 BOTTLETABLET13513
71335-0074-3Phendimetrazine Tartrate180 in 1 BOTTLETABLET18013
71335-0074-4Phendimetrazine Tartrate15 in 1 BOTTLETABLET1513
71335-0074-5Phendimetrazine Tartrate90 in 1 BOTTLETABLET9013
71335-0074-6Phendimetrazine Tartrate7 in 1 BOTTLETABLET713
71335-0074-7Phendimetrazine Tartrate21 in 1 BOTTLETABLET2113
71335-0074-8Phendimetrazine Tartrate60 in 1 BOTTLETABLET6013
71335-0074-9Phendimetrazine Tartrate45 in 1 BOTTLETABLET4513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0074-1EA - Each71335-0074cb397b28-3587-4a9f-a808-75ed4d815cfe12018-03-08
71335-0074-2EA - Each71335-00741860ec4a-c4b4-4bfa-94ec-e243c020856e12018-03-08
71335-0074-3EA - Each71335-0074ce80dab1-97fe-426b-814a-39b156fa3d8412018-03-08
71335-0074-4EA - Each71335-00744d25d3ab-b59b-42ea-9bae-0d9a9d19289e12018-03-08
71335-0074-5EA - Each71335-00742995b18c-414b-4792-aac1-04adc2a2b5e312018-03-08
71335-0074-6EA - Each71335-0074b7aa539f-5afc-4e99-a4af-92f7e201c46c12018-03-08
71335-0074-7EA - Each71335-0074f3da7587-9092-489a-97ba-a36939da25f112018-03-08
71335-0074-8EA - Each71335-007445b74601-937e-4248-b0b5-132eaee7cf9f12018-03-08
71335-0074-9EA - Each71335-007412f44bea-3bea-4441-a41c-24c80055aec712018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0074PHENDIMETRAZINE 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
71335-0074-071335007400120 TABLET in 1 BOTTLE (71335-0074-0) 120 tablet2017-09-180000-00-00NoNoCurrent
71335-0074-17133500740130 TABLET in 1 BOTTLE (71335-0074-1) 30 tablet2017-09-180000-00-00NoNoCurrent
71335-0074-271335007402135 TABLET in 1 BOTTLE (71335-0074-2) 135 tablet2017-09-180000-00-00NoNoCurrent
71335-0074-371335007403180 TABLET in 1 BOTTLE (71335-0074-3) 180 tablet2017-09-180000-00-00NoNoCurrent
71335-0074-47133500740415 TABLET in 1 BOTTLE (71335-0074-4) 15 tablet2017-09-180000-00-00NoNoCurrent
71335-0074-57133500740590 TABLET in 1 BOTTLE (71335-0074-5) 90 tablet2017-09-180000-00-00NoNoCurrent
71335-0074-6713350074067 TABLET in 1 BOTTLE (71335-0074-6) 7 tablet2017-09-180000-00-00NoNoCurrent
71335-0074-77133500740721 TABLET in 1 BOTTLE (71335-0074-7) 21 tablet2017-09-180000-00-00NoNoCurrent
71335-0074-87133500740860 TABLET in 1 BOTTLE (71335-0074-8) 60 tablet2017-09-180000-00-00NoNoCurrent
71335-0074-97133500740945 TABLET in 1 BOTTLE (71335-0074-9) 45 tablet2017-09-180000-00-00NoNoCurrent