Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
70518-2135
11-digit product format
705182135
Labeler code
70518
Product ID
70518-2135_dae30938-7023-641c-e053-2a95a90a4a02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA012462
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-06-07
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2135-07051821350030 TABLET in 1 BLISTER PACK (70518-2135-0) 30 tablet2019-06-070000-00-00NoNoCurrent