FDA.reportPublic FDA data

Phendimetrazine Tartrate

Product NDC
52959-282
11-digit product format
529590282
Labeler code
52959
Product ID
52959-282_76692cfd-6252-450d-e053-2a91aa0a742f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA091042
Marketing category
ANDA
Marketing start
2010-09-15
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
No
Listing certified through
2019-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-282-072020-01-31C16284748780-19d75b9d1-13fe-f424-e053-dadaa90a57ce0282/0886 PHENDIMETRAZINE
52959-282-142020-01-31C16284748780-19d75b9d1-13fe-f424-e053-dadaa90a57ce0282/0886 PHENDIMETRAZINE
52959-282-212020-01-31C16284748780-19d75b9d1-13fe-f424-e053-dadaa90a57ce0282/0886 PHENDIMETRAZINE
52959-282-282020-01-31C16284748780-19d75b9d1-13fe-f424-e053-dadaa90a57ce0282/0886 PHENDIMETRAZINE
52959-282-302020-01-31C16284748780-19d75b9d1-13fe-f424-e053-dadaa90a57ce0282/0886 PHENDIMETRAZINE
52959-282-352020-01-31C16284748780-19d75b9d1-13fe-f424-e053-dadaa90a57ce0282/0886 PHENDIMETRAZINE
52959-282-422020-01-31C16284748780-19d75b9d1-13fe-f424-e053-dadaa90a57ce0282/0886 PHENDIMETRAZINE
52959-282-602020-01-31C16284748780-19d75b9d1-13fe-f424-e053-dadaa90a57ce0282/0886 PHENDIMETRAZINE
52959-282-902020-01-31C16284748780-19d75b9d1-13fe-f424-e053-dadaa90a57ce0282/0886 PHENDIMETRAZINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-282-07Phendimetrazine Tartrate7 in 1 BOTTLETABLET72
52959-282-14Phendimetrazine Tartrate14 in 1 BOTTLETABLET142
52959-282-21Phendimetrazine Tartrate21 in 1 BOTTLETABLET212
52959-282-28Phendimetrazine Tartrate28 in 1 BOTTLETABLET282
52959-282-30Phendimetrazine Tartrate30 in 1 BOTTLETABLET302
52959-282-35Phendimetrazine Tartrate35 in 1 BOTTLETABLET352
52959-282-42Phendimetrazine Tartrate42 in 1 BOTTLETABLET422
52959-282-60Phendimetrazine Tartrate60 in 1 BOTTLETABLET602
52959-282-90Phendimetrazine Tartrate90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-282-14EA - Each52959-2824051d3d8-b903-46c7-a67d-1e5f6403f65e12012-07-24
52959-282-21EA - Each52959-282a8a85b55-a4b9-4817-93ec-b923687c479d12012-07-24
52959-282-28EA - Each52959-282c2a0d0a7-9440-4447-9560-bdfc82cbb01812012-07-24
52959-282-30EA - Each52959-282376ada12-78c2-4cff-84bb-b1ed5d3de55912012-07-24
52959-282-35EA - Each52959-28263bd9178-c68e-4391-a3aa-b1cad205629812012-07-24
52959-282-42EA - Each52959-282dd4bafaf-1e84-46ab-8cb1-e9991fc65ef112012-07-24
52959-282-90EA - Each52959-2820a3a742a-ab34-4120-946b-cbb9cf860d2812012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-282PHENDIMETRAZINE TARTRATE ER (PHENDIMETRAZINE TARTRATE) CAPSULE, EXTENDED RELEASE PHENDIMETRAZINE TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 9 package rows20180922_49b13acc-c7a9-4f7c-bcc2-2c73fcedab52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979543phendimetrazine tartrate 105 MG 24HR Extended Release Oral CapsulePSN49b13acc-c7a9-4f7c-bcc2-2c73fcedab522
979549phendimetrazine tartrate 35 MG Oral TabletPSN49b13acc-c7a9-4f7c-bcc2-2c73fcedab522
97954324 HR phendimetrazine tartrate 105 MG Extended Release Oral CapsuleSCD49b13acc-c7a9-4f7c-bcc2-2c73fcedab522
979549phendimetrazine tartrate 35 MG Oral TabletSCD49b13acc-c7a9-4f7c-bcc2-2c73fcedab522
979543phendimetrazine 105 MG 24 HR Extended Release Oral CapsuleSY49b13acc-c7a9-4f7c-bcc2-2c73fcedab522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-282-07529590282077 in 1 BOTTLEHistorical
52959-282-145295902821414 in 1 BOTTLEHistorical
52959-282-215295902822121 in 1 BOTTLEHistorical
52959-282-285295902822828 in 1 BOTTLEHistorical
52959-282-305295902823030 in 1 BOTTLEHistorical
52959-282-355295902823535 in 1 BOTTLEHistorical
52959-282-425295902824242 in 1 BOTTLEHistorical
52959-282-605295902826060 in 1 BOTTLEHistorical
52959-282-905295902829090 in 1 BOTTLEHistorical