DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Product NDC
61919-080
11-digit product format
619190080
Labeler code
61919
Product ID
61919-080_35e360f7-dbf3-5dd9-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
NDA012462
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-01-01
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
E
Listing certified through
2017-12-31
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
61919-080-102020-01-31C16284748780-19d75b9d0-fc8b-f424-e053-dadaa90a57ceDiphen HCL Atropine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-080-10DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE10 in 1 BOTTLETABLET102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-080-10EA - Each61919-080bc6ec621-02ff-44c6-b32c-cfd6ed52d33812015-09-10

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-080DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DIRECT RX]2Legacy NDC, 1 package rows20160926_8c59e8c6-4fc0-4c30-95ab-740b84e352e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN8c59e8c6-4fc0-4c30-95ab-740b84e352e12
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD8c59e8c6-4fc0-4c30-95ab-740b84e352e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-080-106191900801010 in 1 BOTTLEHistorical