Phendimetrazine Tartrate

Product NDC
33261-390
11-digit product format
332610390
Labeler code
33261
Product ID
33261-390_a815119a-0cf9-4dfd-9c17-aa9af6e52585
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA018074
Marketing category
NDA
Marketing start
1977-09-06
Marketing end
0000-00-00
Substance
PHENDIMETRAZINE TARTRATE
Active strength
105 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-390-14Phendimetrazine Tartrate14 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE141
33261-390-28Phendimetrazine Tartrate28 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE281

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-390-14EA - Each33261-390b3e96b40-e895-47e7-bd1c-6d2522d8189212015-10-02
33261-390-28EA - Each33261-390a8f86ace-f0a2-4fa1-8ee3-1145070b234112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
PHENDIMETRAZINEACTIVE MOIETYAB2794W8KVPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554PHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-390PHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140128_79c40fc0-bfd0-4a35-bb3f-5193a9930f7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979543phendimetrazine tartrate 105 MG 24HR Extended Release Oral CapsulePSN79c40fc0-bfd0-4a35-bb3f-5193a9930f7c1
97954324 HR phendimetrazine tartrate 105 MG Extended Release Oral CapsuleSCD79c40fc0-bfd0-4a35-bb3f-5193a9930f7c1
979543phendimetrazine 105 MG 24 HR Extended Release Oral CapsuleSY79c40fc0-bfd0-4a35-bb3f-5193a9930f7c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-390-143326103901414 in 1 BOTTLE, PLASTICHistorical
33261-390-283326103902828 in 1 BOTTLE, PLASTICHistorical