Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
50090-3456
11-digit product format
500903456
Labeler code
50090
Product ID
50090-3456_2df9b7b8-8617-4cb0-a344-98c330880d3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA086727
Marketing category
ANDA
Marketing start
2017-07-07
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3456-0EA - Each50090-3456f79a2ad8-403e-45c4-9a6b-28b7c05bbaa112018-11-06
50090-3456-1EA - Each50090-345697a17122-0f6b-42bf-9f84-eb43c7af6b7c12021-09-07
50090-3456-2EA - Each50090-345628a017a7-d7d0-47d0-9093-e480bbbaeb4c12018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3456-05009034560015 TABLET in 1 BOTTLE (50090-3456-0) 15 tablet2018-05-170000-00-00NoNoCurrent
50090-3456-15009034560120 TABLET in 1 BOTTLE, PLASTIC (50090-3456-1) 20 tablet2017-07-070000-00-00NoNoCurrent
50090-3456-25009034560230 TABLET in 1 BOTTLE (50090-3456-2) 30 tablet2018-05-250000-00-00NoNoCurrent