Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
50090-0039
11-digit product format
500900039
Labeler code
50090
Product ID
50090-0039_82cb54e0-b84e-4029-a8e0-9b22bc2144b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA085762
Marketing category
ANDA
Marketing start
1977-11-17
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0039-0Diphenoxylate Hydrochloride and Atropine Sulfate15 in 1 BOTTLE, PLASTICTABLET1512
50090-0039-1Diphenoxylate Hydrochloride and Atropine Sulfate20 in 1 BOTTLE, PLASTICTABLET2012
50090-0039-2Diphenoxylate Hydrochloride and Atropine Sulfate30 in 1 BOTTLE, PLASTICTABLET3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0039-0EA - Each50090-00394355b9fb-a331-4ef0-b800-657407bbdeba12018-08-13
50090-0039-1EA - Each50090-003942fcccd8-987e-41ff-9909-0c35409aef8412018-08-13
50090-0039-2EA - Each50090-003963e84855-e6c0-4f74-ab83-8487b92382f212018-08-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0039DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS]12Legacy NDC, 3 package rows20200122_4606e3af-badc-4584-855e-3993a915467c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN4606e3af-badc-4584-855e-3993a915467c12
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD4606e3af-badc-4584-855e-3993a915467c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0039-05009000390015 in 1 BOTTLE, PLASTICHistorical
50090-0039-15009000390120 TABLET in 1 BOTTLE, PLASTIC (50090-0039-1) 20 tablet2014-11-280000-00-00NoNoCurrent
50090-0039-25009000390230 TABLET in 1 BOTTLE, PLASTIC (50090-0039-2) 30 tablet2014-11-280000-00-00NoNoCurrent