Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
63629-9175
11-digit product format
636299175
Labeler code
63629
Product ID
63629-9175_612bfccb-4bb2-421f-9b21-0bab405ca717
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207128
Marketing category
ANDA
Marketing start
2020-10-21
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9175-1EA - Each63629-9175039990ce-9ca8-4fcf-943b-e070285b06f012022-05-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9175-163629917501100 TABLET in 1 BOTTLE (63629-9175-1) 100 tablet2022-04-040000-00-00NoNoCurrent