Phendimetrazine Tartrate

Product NDC
10702-078
11-digit product format
107020078
Labeler code
10702
Product ID
10702-078_289ebb0b-370d-4ea1-e063-6394a90a1752
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
KVK-TECH, INC
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
10702-078-01Phendimetrazine Tartrate100 in 1 BOTTLETABLET1007
10702-078-03Phendimetrazine Tartrate30 in 1 BOTTLETABLET307
10702-078-10Phendimetrazine Tartrate1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-078-01EA - Each10702-078ac16e30d-9cc0-45f9-aef2-a17e0eb3882e12012-07-24
10702-078-03EA - Each10702-0781eb678ff-cf75-4a3a-95cc-8ad8f9a2ea4b12012-07-24
10702-078-10EA - Each10702-0783d0fa0b9-7780-4426-af94-529f9b3f118112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE TABLET [KVK-TECH, INC]2
PHENDIMETRAZINEACTIVE MOIETYAB2794W8KVPHENDIMETRAZINE TARTRATE TABLET [KVK-TECH, INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENDIMETRAZINE TARTRATE TABLET [KVK-TECH, INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENDIMETRAZINE TARTRATE TABLET [KVK-TECH, INC]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MPHENDIMETRAZINE TARTRATE TABLET [KVK-TECH, INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENDIMETRAZINE TARTRATE TABLET [KVK-TECH, INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENDIMETRAZINE TARTRATE TABLET [KVK-TECH, INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENDIMETRAZINE TARTRATE TABLET [KVK-TECH, INC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PHENDIMETRAZINE TARTRATE TABLET [KVK-TECH, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-078PHENDIMETRAZINE TARTRATE TABLET [KVK-TECH, INC]7Current NDC, Legacy NDC, 3 package rows20241208_07bf3488-09e7-436f-af3f-94c35a7be025.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979549phendimetrazine tartrate 35 MG Oral TabletPSNef4cfd54-7d3e-4571-ae77-38ab2fd1af3d24
979549phendimetrazine tartrate 35 MG Oral TabletSCDef4cfd54-7d3e-4571-ae77-38ab2fd1af3d24
979549phendimetrazine tartrate 35 MG Oral TabletPSN1c2370fd-6b40-48dc-a42d-2488041d5b3713
979549phendimetrazine tartrate 35 MG Oral TabletSCD1c2370fd-6b40-48dc-a42d-2488041d5b3713
979549phendimetrazine tartrate 35 MG Oral TabletPSN767b5386-1e56-4eeb-8d59-510b940ab75e8
979549phendimetrazine tartrate 35 MG Oral TabletSCD767b5386-1e56-4eeb-8d59-510b940ab75e8
979549phendimetrazine tartrate 35 MG Oral TabletPSN07bf3488-09e7-436f-af3f-94c35a7be0257
979549phendimetrazine tartrate 35 MG Oral TabletSCD07bf3488-09e7-436f-af3f-94c35a7be0257
979549phendimetrazine tartrate 35 MG Oral TabletPSN342bc2a2-2751-b51a-e063-6394a90a4c431
979549phendimetrazine tartrate 35 MG Oral TabletSCD342bc2a2-2751-b51a-e063-6394a90a4c431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-078-0110702007801100 TABLET in 1 BOTTLE (10702-078-01) 100 tablet2010-09-150000-00-00NoNoCurrent
10702-078-031070200780330 TABLET in 1 BOTTLE (10702-078-03) 30 tablet2010-09-150000-00-00NoNoCurrent
10702-078-10107020078101000 TABLET in 1 BOTTLE (10702-078-10) 1000 tablet2010-09-150000-00-00NoNoCurrent