Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
63629-1934
11-digit product format
636291934
Labeler code
63629
Product ID
63629-1934_33873e15-fd98-40f4-9877-82802fd0562a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA086727
Marketing category
ANDA
Marketing start
2017-07-07
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1934-1EA - Each63629-1934a375b1b2-aa92-43c9-a6dc-bd94c196763312021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1934-1636291934011000 TABLET in 1 BOTTLE (63629-1934-1) 1000 tablet2021-01-130000-00-00NoNoCurrent