FDA.reportPublic FDA data

Phendimetrazine Tartrate

Product NDC
0185-5254
11-digit product format
001855254
Labeler code
0185
Product ID
0185-5254_876d4cfa-fc00-4fab-b2c7-fa4aea7bd398
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Eon Labs, Inc.
Application
NDA018074
Marketing category
NDA
Marketing start
1977-09-06
Marketing end
2022-11-30
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
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
0185-5254-01EA - Each0185-5254053a7c27-6ea5-4651-bdaf-58fbe2737e9d12012-07-24
0185-5254-10EA - Each0185-525497ea3a5a-b27a-41b0-8175-4c20f796388012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
PHENDIMETRAZINEACTIVE MOIETYAB2794W8KVPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554PHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
PHENDIMETRAZINEACTIVE MOIETYAB2794W8KVPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]2
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979543phendimetrazine tartrate 105 MG 24HR Extended Release Oral CapsulePSN5803a3c0-7434-40f3-af5e-cf33b3e2c4485
97954324 HR phendimetrazine tartrate 105 MG Extended Release Oral CapsuleSCD5803a3c0-7434-40f3-af5e-cf33b3e2c4485
979543phendimetrazine 105 MG 24 HR Extended Release Oral CapsuleSY5803a3c0-7434-40f3-af5e-cf33b3e2c4485
979543phendimetrazine tartrate 105 MG 24HR Extended Release Oral CapsulePSN67e2f269-b73d-4ff5-8177-ecf79536648c3
97954324 HR phendimetrazine tartrate 105 MG Extended Release Oral CapsuleSCD67e2f269-b73d-4ff5-8177-ecf79536648c3
979543phendimetrazine 105 MG 24 HR Extended Release Oral CapsuleSY67e2f269-b73d-4ff5-8177-ecf79536648c3
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0185-5254-0100185525401100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0185-5254-01) 1977-09-062022-10-31NoNoCurrent
0185-5254-10001855254101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0185-5254-10) 1977-09-062022-11-30NoNoCurrent