Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
67296-1241
11-digit product format
672961241
Labeler code
67296
Product ID
67296-1241_d61031d4-3dc4-1d54-e053-2995a90acf69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
NDA012462
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-02-27
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
67296-1241-12024-01-30C16284748780-11030e365-21b1-111a-e063-dadaa90a10e24f457a86-b920-5b53-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1241-1Diphenoxylate Hydrochloride and Atropine Sulfate15 in 1 BOTTLETABLET154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1241DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20220121_4f457a86-b920-5b53-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN4f457a86-b920-5b53-e054-00144ff8d46c4
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD4f457a86-b920-5b53-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1241-16729612410115 TABLET in 1 BOTTLE (67296-1241-1) 15 tablet2013-02-270000-00-00NoNoCurrent