Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
68788-7021
11-digit product format
687887021
Labeler code
68788
Product ID
68788-7021_bc399910-b6b5-48cf-8f0e-de41b8318a9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA086727
Marketing category
ANDA
Marketing start
2017-10-11
Marketing end
0000-00-00
Substance
DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
Active strength
3 mg/1; mg/1
Pharmacologic classes
Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7021-16878870210110 TABLET in 1 BOTTLE (68788-7021-1) 10 tablet2017-10-110000-00-00NoNoCurrent
68788-7021-26878870210220 TABLET in 1 BOTTLE (68788-7021-2) 20 tablet2017-10-110000-00-00NoNoCurrent
68788-7021-36878870210330 TABLET in 1 BOTTLE (68788-7021-3) 30 tablet2017-10-110000-00-00NoNoCurrent
68788-7021-76878870210721 TABLET in 1 BOTTLE (68788-7021-7) 21 tablet2017-10-110000-00-00NoNoCurrent