Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
60687-569
11-digit product format
606870569
Labeler code
60687
Product ID
60687-569_cdc2b0c3-1054-4412-e053-2a95a90abc4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA085372
Marketing category
ANDA
Marketing start
2020-10-01
Marketing end
2022-08-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-569-0160687056901100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-569-01) > 1 TABLET in 1 BLISTER PACK (60687-569-11) 100 blister pack2020-10-010000-00-00NoNoCurrent