PHENDIMETRAZINE TARTRATE

Product NDC
64850-440
11-digit product format
648500440
Labeler code
64850
Product ID
64850-440_97b69c02-a69e-46fe-8686-4b4d8ceb5dca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Elite Laboratories, Inc
Application
ANDA040762
Marketing category
ANDA
Marketing start
2012-11-20
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
64850-440-01PHENDIMETRAZINE TARTRATE100 in 1 BOTTLETABLET1002
64850-440-10PHENDIMETRAZINE TARTRATE1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64850-440-01EA - Each64850-44060a33634-4b61-4d5f-817a-246696eabb5112023-03-13
64850-440-10EA - Each64850-4406c1ca0bb-84f8-4d39-a462-e09eb3596c8112023-03-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC]1
PHENDIMETRAZINEACTIVE MOIETYAB2794W8KVPHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BPHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64850-440PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC]2Current NDC, Legacy NDC, 2 package rows20190208_42ecacde-6859-47c6-ba44-13fb4f3b5448.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979549phendimetrazine tartrate 35 MG Oral TabletPSN8593421c-d1fb-409d-a5bb-3369da18fd2c102
979549phendimetrazine tartrate 35 MG Oral TabletSCD8593421c-d1fb-409d-a5bb-3369da18fd2c102
979549phendimetrazine tartrate 35 MG Oral TabletPSN05bb0569-4eed-2139-e063-6394a90acb6c4
979549phendimetrazine tartrate 35 MG Oral TabletSCD05bb0569-4eed-2139-e063-6394a90acb6c4
979549phendimetrazine tartrate 35 MG Oral TabletPSN42ecacde-6859-47c6-ba44-13fb4f3b54482
979549phendimetrazine tartrate 35 MG Oral TabletSCD42ecacde-6859-47c6-ba44-13fb4f3b54482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64850-440-0164850044001100 TABLET in 1 BOTTLE (64850-440-01) 100 tablet2012-11-200000-00-00NoNoCurrent
64850-440-10648500440101000 TABLET in 1 BOTTLE (64850-440-10) 1000 tablet2012-11-200000-00-00NoNoCurrent