Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
50090-3452
11-digit product format
500903452
Labeler code
50090
Product ID
50090-3452_470e4ea5-d192-49d1-8883-cc75f75ea3e7
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3452-02023-02-06C16284748780-1f386c649-a5ba-0266-e053-dadaa90a7c1a96e19512-870e-4eaf-b9e2-ae223371159c
50090-3452-02023-01-30C16284748780-1f386c649-a5ba-0266-e053-dadaa90a7c1a96e19512-870e-4eaf-b9e2-ae223371159c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3452-0EA - Each50090-34521279b603-7b38-46e7-bd41-d6a441cfb25e12019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3452-05009034520020 TABLET in 1 BOTTLE (50090-3452-0) 20 tablet2018-05-090000-00-00NoNoCurrent