Diphenoxylate hydrochloride and atropine sulfate

Product NDC
71610-566
11-digit product format
716100566
Labeler code
71610
Product ID
71610-566_99e98faa-0c9a-4870-aabd-0edece49ff6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate hydrochloride and Atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, 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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-566-30EA - Each71610-566bbe8af79-b70d-40a5-af0d-72412cb167fe12021-08-05
71610-566-53EA - Each71610-566848c56fb-af06-4544-8467-4beab23bc97312021-08-05
71610-566-60EA - Each71610-56623ea013e-4f27-42e5-beaa-f2af9a96c65312021-08-05
71610-566-80EA - Each71610-56697adad9c-7901-44ce-a369-0e6168d6931d12021-08-05
71610-566-90EA - Each71610-566cb97ddb4-db27-4d3b-b63b-32a3613acd7d12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-566DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20210723_285ceb16-8cad-48cf-adaa-3d3136a82a8f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-566-307161005663030 TABLET in 1 BOTTLE (71610-566-30) 30 tablet2021-07-150000-00-00NoNoCurrent
71610-566-537161005665360 TABLET in 1 BOTTLE (71610-566-53) 60 tablet2021-06-090000-00-00NoNoCurrent
71610-566-607161005666090 TABLET in 1 BOTTLE (71610-566-60) 90 tablet2021-06-090000-00-00NoNoCurrent
71610-566-7071610056670120 TABLET in 1 BOTTLE (71610-566-70) 120 tablet2021-06-090000-00-00NoNoCurrent
71610-566-8071610056680180 TABLET in 1 BOTTLE (71610-566-80) 180 tablet2021-06-090000-00-00NoNoCurrent
71610-566-9071610056690240 TABLET in 1 BOTTLE (71610-566-90) 240 tablet2021-06-090000-00-00NoNoCurrent