FDA.reportPublic FDA data

Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
50090-2872
11-digit product format
500902872
Labeler code
50090
Product ID
50090-2872_f08adf6c-07ad-4b96-b85f-1646152b9a29
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
50090-2872-02023-01-30C16284748780-1f386c649-ad28-0266-e053-dadaa90a7c1aDiphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use C-V
50090-2872-12023-01-30C16284748780-1f386c649-ad28-0266-e053-dadaa90a7c1aDiphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use C-V
50090-2872-22023-01-30C16284748780-1f386c649-ad28-0266-e053-dadaa90a7c1aDiphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use C-V

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2872-0Diphenoxylate Hydrochloride and Atropine Sulfate15 in 1 BOTTLETABLET1511
50090-2872-1Diphenoxylate Hydrochloride and Atropine Sulfate20 in 1 BOTTLETABLET2011
50090-2872-2Diphenoxylate Hydrochloride and Atropine Sulfate30 in 1 BOTTLETABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2872-0EA - Each50090-2872e1a71780-7acf-4f80-a5e9-e77f47e8c9e212019-04-11
50090-2872-1EA - Each50090-2872c1ce8201-4a4d-4bc5-8d63-826dc67e5ebd12019-04-11
50090-2872-2EA - Each50090-28720ebca404-1335-441b-9aa6-5c3bac80f57412019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2872DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS]11Legacy NDC, 3 package rows20200122_aae3896d-0e79-480d-8a9d-a12ff2e0318a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSNaae3896d-0e79-480d-8a9d-a12ff2e0318a11
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDaae3896d-0e79-480d-8a9d-a12ff2e0318a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2872-05009028720015 TABLET in 1 BOTTLE (50090-2872-0) 15 tablet2017-02-160000-00-00NoNoCurrent
50090-2872-15009028720120 TABLET in 1 BOTTLE (50090-2872-1) 20 tablet2017-03-020000-00-00NoNoCurrent
50090-2872-25009028720230 TABLET in 1 BOTTLE (50090-2872-2) 30 tablet2017-03-020000-00-00NoNoCurrent