Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
66267-780
11-digit product format
662670780
Labeler code
66267
Product ID
66267-780_9cbd5bda-f961-1914-e053-2995a90afd6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-780-04662670780044 TABLET in 1 BOTTLE (66267-780-04) 4 tablet2017-02-130000-00-00NoNoCurrent