Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
17856-1061
11-digit product format
178561061
Labeler code
17856
Product ID
17856-1061_2fd64c85-4b05-4479-ac8a-883c39074539
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
NDA012462
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-02-27
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-1061-12020-01-31C16284748780-19d75b9d0-314b-f424-e053-dadaa90a57ceDiphenoxylate Hydrochloride and Atropine Sulfate Cv, Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1061-1Diphenoxylate Hydrochloride and Atropine Sulfate1 in 1 DOSE PACKTABLET13
17856-1061-1Diphenoxylate Hydrochloride and Atropine Sulfate100 in 1 CONTAINERTABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1061DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [ATLANTIC BIOLOGICALS CORPS]3Legacy NDC, 2 package rows20170616_dec09873-1ccc-4efe-918d-337b3926384d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSNdec09873-1ccc-4efe-918d-337b3926384d3
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDdec09873-1ccc-4efe-918d-337b3926384d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
17856-1061-1178561061011 in 1 DOSE PACKHistorical