FDA.reportPublic FDA data

Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
53002-3401
11-digit product format
530023401
Labeler code
53002
Product ID
53002-3401_71fd5b2d-290f-47b4-9e4a-54404e27b3c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA213413
Marketing category
ANDA
Marketing start
2020-03-15
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 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
53002-3401-12025-01-30C16284748780-12cef2736-b099-d83d-e063-dadaa90ab31fDiphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V
53002-3401-22025-01-30C16284748780-12cef2736-b099-d83d-e063-dadaa90ab31fDiphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V
53002-3401-32025-01-30C16284748780-12cef2736-b099-d83d-e063-dadaa90ab31fDiphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3401-1Diphenoxylate Hydrochloride and Atropine Sulfate10 in 1 BOTTLETABLET101
53002-3401-2Diphenoxylate Hydrochloride and Atropine Sulfate20 in 1 BOTTLETABLET201
53002-3401-3Diphenoxylate Hydrochloride and Atropine Sulfate30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3401DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20220331_23791c11-028a-41d3-9894-c75c6effa0f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN23791c11-028a-41d3-9894-c75c6effa0f31
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD23791c11-028a-41d3-9894-c75c6effa0f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3401-15300234010110 TABLET in 1 BOTTLE (53002-3401-1) 10 tablet2021-01-010000-00-00NoNoCurrent
53002-3401-25300234010220 TABLET in 1 BOTTLE (53002-3401-2) 20 tablet2021-01-010000-00-00NoNoCurrent
53002-3401-35300234010330 TABLET in 1 BOTTLE (53002-3401-3) 30 tablet2021-01-010000-00-00NoNoCurrent