Diphenoxylate hydrochloride and atropine sulfate

Product NDC
0832-0590
11-digit product format
008320590
Labeler code
0832
Product ID
0832-0590_20d950d6-1727-4e76-a126-a973a505a027
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate hydrochloride and Atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA210571
Marketing category
ANDA
Marketing start
2018-08-31
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0590-10EA - Each0832-0590471ef6cb-1cd3-4832-8040-4915bfa8a84e12018-10-11
0832-0590-11EA - Each0832-059093a32609-66f9-40f9-aa0a-1c101bb83c9f12018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-0590-10008320590101000 TABLET in 1 BOTTLE (0832-0590-10) 1000 tablet2018-08-310000-00-00NoNoCurrent
0832-0590-1100832059011100 TABLET in 1 BOTTLE (0832-0590-11) 100 tablet2018-08-310000-00-00NoNoCurrent
0832-0590-900083205909090 TABLET in 1 BOTTLE (0832-0590-90) 90 tablet2018-08-310000-00-00NoNoCurrent