Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
17856-3194
11-digit product format
178563194
Labeler code
17856
Product ID
17856-3194_3362fdb8-3317-4bec-b42b-db6b54b2768a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA087708
Marketing category
ANDA
Marketing start
1982-05-03
Marketing end
0000-00-00
Substance
DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
Active strength
3 mg/5mL; mg/5mL
Pharmacologic classes
Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
DEA schedule
CV
NDC exclude flag
E
Listing certified through
2018-12-31
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
17856-3194-52020-01-31C16284748780-19d75b9d0-f2d7-f424-e053-dadaa90a57ceDiphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-3194-5Diphenoxylate Hydrochloride and Atropine Sulfate5 mL in 1 CUPSOLUTION52
17856-3194-5Diphenoxylate Hydrochloride and Atropine Sulfate72 in 1 BOXSOLUTION722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-3194DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 2 package rows20171221_b0c91667-ab6f-481d-a592-62da8a52abf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral SolutionPSNb0c91667-ab6f-481d-a592-62da8a52abf72
1190568atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral SolutionSCDb0c91667-ab6f-481d-a592-62da8a52abf72
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral SolutionSYb0c91667-ab6f-481d-a592-62da8a52abf72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-3194-5178563194055 mL in 1 CUP5 mlHistorical