Phendimetrazine Tartrate

Product NDC
21695-597
11-digit product format
216950597
Labeler code
21695
Product ID
21695-597_f31c768e-4156-4ebe-8dce-763bf940ab1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA085588
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
0000-00-00
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
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-597-07Phendimetrazine Tartrate7 in 1 BOTTLETABLET71
21695-597-21Phendimetrazine Tartrate21 in 1 BOTTLETABLET211
21695-597-42Phendimetrazine Tartrate42 in 1 BOTTLETABLET421
21695-597-60Phendimetrazine Tartrate60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-597-07EA - Each21695-5971dc5d3f4-c694-4cd5-b9b5-eb121930530e12012-07-24
21695-597-21EA - Each21695-597c114c4f5-8d6c-4a57-936e-e9128e6005a612012-07-24
21695-597-42EA - Each21695-597c07efac2-3c54-4f61-a2c7-3c6ee5e02fe512012-07-24
21695-597-60EA - Each21695-597cf03ec17-41c5-4a54-b5bd-55c2c4c09a7a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]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. 6INACTIVE INGREDIENTH77VEI93A8PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-597PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20110113_f31c768e-4156-4ebe-8dce-763bf940ab1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979549phendimetrazine tartrate 35 MG Oral TabletPSNf31c768e-4156-4ebe-8dce-763bf940ab1b1
979549phendimetrazine tartrate 35 MG Oral TabletSCDf31c768e-4156-4ebe-8dce-763bf940ab1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-597-07216950597077 in 1 BOTTLEHistorical
21695-597-212169505972121 in 1 BOTTLEHistorical
21695-597-422169505974242 in 1 BOTTLEHistorical
21695-597-602169505976060 in 1 BOTTLEHistorical