Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
63187-254
11-digit product format
631870254
Labeler code
63187
Product ID
63187-254_948fb463-1798-4f1c-880e-15a62ca86fa8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA085762
Marketing category
ANDA
Marketing start
1977-11-17
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

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-254DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [PROFICIENT RX LP]4Legacy NDC20200131_4148ea73-47a7-46d6-9b10-a815afc9c463.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-254-156318702541515 TABLET in 1 BOTTLE, PLASTIC (63187-254-15) 15 tablet2019-01-010000-00-00NoNoCurrent
63187-254-206318702542020 TABLET in 1 BOTTLE, PLASTIC (63187-254-20) 20 tablet2019-01-010000-00-00NoNoCurrent
63187-254-306318702543030 TABLET in 1 BOTTLE, PLASTIC (63187-254-30) 30 tablet2019-01-010000-00-00NoNoCurrent
63187-254-606318702546060 TABLET in 1 BOTTLE, PLASTIC (63187-254-60) 60 tablet2019-01-010000-00-00NoNoCurrent
63187-254-906318702549090 TABLET in 1 BOTTLE, PLASTIC (63187-254-90) 90 tablet2019-01-010000-00-00NoNoCurrent