Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
50090-2641
11-digit product format
500902641
Labeler code
50090
Product ID
50090-2641_69712f61-ab43-4741-a53a-94eb2d2ba5ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
No
Listing certified through
2021-12-31
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
50090-2641-02023-01-30C16284748780-1f386c64a-4416-0266-e053-dadaa90a7c1aDiphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use C-V

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2641-0Diphenoxylate Hydrochloride and Atropine Sulfate20 in 1 BOTTLETABLET2012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2641-0EA - Each50090-26412648bd15-8252-47a2-b4f6-da392196d2a512019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2641DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS]12Legacy NDC, 1 package rows20200122_f3e23860-264c-4a93-aa78-0722cd5187ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSNf3e23860-264c-4a93-aa78-0722cd5187ab12
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDf3e23860-264c-4a93-aa78-0722cd5187ab12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2641-05009026410020 TABLET in 1 BOTTLE (50090-2641-0) 20 tablet2016-11-220000-00-00NoNoCurrent