FDA.reportPublic FDA data

Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
50090-5592
11-digit product format
500905592
Labeler code
50090
Product ID
50090-5592_a756536d-01bf-4487-b796-a22d49eff381
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213413
Marketing category
ANDA
Marketing start
2020-03-15
Substance
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Active strength
.025; 2.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenoxylate Hydrochloride and Atropine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.025 mg/1
DIPHENOXYLATE HYDROCHLORIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5, W24OD7YW48
Rxcui1190572

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
50090-5592-02023-02-07C16284748780-1f386c64a-34fd-0266-e053-dadaa90a7c1aDiphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V
50090-5592-02023-01-30C16284748780-1f386c64a-34fd-0266-e053-dadaa90a7c1aDiphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5592-0Diphenoxylate Hydrochloride and Atropine Sulfate20 in 1 BOTTLETABLET203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5592DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20230208_24077113-11b2-4cde-afa7-1a1e364173c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN24077113-11b2-4cde-afa7-1a1e364173c23
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD24077113-11b2-4cde-afa7-1a1e364173c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5592-05009055920020 TABLET in 1 BOTTLE (50090-5592-0) 20 tablet2021-07-120000-00-00NoNoCurrent