DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Product NDC
61919-405
11-digit product format
619190405
Labeler code
61919
Product ID
61919-405_ea4e5146-9c7b-ecaa-e053-2a95a90a2de7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA086727
Marketing category
ANDA
Marketing start
2019-06-12
Marketing end
0000-00-00
Substance
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Active strength
0 mg/1; mg/1
Pharmacologic classes
Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-405-20EA - Each61919-4052a09bb69-3d67-4ba7-bf01-fe04554b925012019-09-05
61919-405-30EA - Each61919-405de28fed1-b3cc-48a3-a0ff-f0aba9da06cd12019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-405-206191904052020 TABLET in 1 BOTTLE (61919-405-20) 20 tablet2018-03-130000-00-00NoNoCurrent
61919-405-306191904053030 TABLET in 1 BOTTLE (61919-405-30) 30 tablet2019-06-120000-00-00NoNoCurrent