Phendimetrazine Tartrate

Product NDC
0185-4057
11-digit product format
001854057
Labeler code
0185
Product ID
0185-4057_17fbdc0f-dacb-43ec-a3b2-99c52dd2fe1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA085588
Marketing category
ANDA
Marketing start
1977-08-19
Marketing end
2024-01-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-4057-01EA - Each0185-4057967fc014-f8f2-42ce-b573-98406751f68812012-07-24
0185-4057-10EA - Each0185-405703014348-a3c1-4630-a512-d1338cced59c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC]1
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1
PHENDIMETRAZINEACTIVE MOIETYAB2794W8KVPHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC]1
PHENDIMETRAZINEACTIVE MOIETYAB2794W8KVPHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MPHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554PHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979549phendimetrazine tartrate 35 MG Oral TabletPSNa8802ede-d04e-4d2c-8f1d-fd456a5b5e5810
979549phendimetrazine tartrate 35 MG Oral TabletSCDa8802ede-d04e-4d2c-8f1d-fd456a5b5e5810
979549phendimetrazine tartrate 35 MG Oral TabletPSN79719e0a-587f-4f60-a8e5-a28edf5bd7da1
979549phendimetrazine tartrate 35 MG Oral TabletPSNf31c768e-4156-4ebe-8dce-763bf940ab1b1
979549phendimetrazine tartrate 35 MG Oral TabletSCD79719e0a-587f-4f60-a8e5-a28edf5bd7da1
979549phendimetrazine tartrate 35 MG Oral TabletSCDf31c768e-4156-4ebe-8dce-763bf940ab1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0185-4057-0100185405701100 TABLET in 1 BOTTLE (0185-4057-01) 100 tablet1977-08-192024-01-31NoNoCurrent
0185-4057-10001854057101000 TABLET in 1 BOTTLE (0185-4057-10) 1000 tablet1977-08-192023-10-31NoNoCurrent