PHENDIMETRAZINE TARTRATE

Product NDC
69543-409
11-digit product format
695430409
Labeler code
69543
Product ID
69543-409_67788713-a4bc-480f-858a-606cd0d0800b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENDIMETRAZINE TARTRATE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Virtus Pharmaceuticals, LLC
Application
NDA018074
Marketing category
NDA
Marketing start
2018-07-01
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
2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-409-10EA - Each69543-409e4c06ce5-8675-4024-b928-58e087fdacfd12018-08-13
69543-409-30EA - Each69543-409c78c6a48-8ce7-4962-b4b6-5d5b88c3ba9d12021-06-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979543phendimetrazine tartrate 105 MG 24HR Extended Release Oral CapsulePSN40787112-bb0a-4e85-a3f1-8719e3d21fb01
97954324 HR phendimetrazine tartrate 105 MG Extended Release Oral CapsuleSCD40787112-bb0a-4e85-a3f1-8719e3d21fb01
979543phendimetrazine 105 MG 24 HR Extended Release Oral CapsuleSY40787112-bb0a-4e85-a3f1-8719e3d21fb01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69543-409-1069543040910100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69543-409-10) 2018-07-012023-08-31NoNoCurrent
69543-409-11695430409111000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69543-409-11) 2018-11-130000-00-00NoNoCurrent
69543-409-306954304093030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69543-409-30) 2021-05-010000-00-00NoNoCurrent