FENDIQUE ER

Product NDC
69543-413
11-digit product format
695430413
Labeler code
69543
Product ID
69543-413_81f0a7b1-ab31-43e1-b742-cf693ab1b26b
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
2020-03-18
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
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69543-413-1069543041310100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69543-413-10) 2020-03-180000-00-00NoNoCurrent
69543-413-11695430413111000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69543-413-11) 2020-03-180000-00-00NoNoCurrent
69543-413-306954304133030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69543-413-30) 2020-11-130000-00-00NoNoCurrent