FDA.reportPublic FDA data

Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
71335-1693
11-digit product format
713351693
Labeler code
71335
Product ID
71335-1693_30c2b613-bd3c-46d0-b344-cf46d7a9c616
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1693-1Diphenoxylate Hydrochloride and Atropine Sulfate20 in 1 BOTTLETABLET204
71335-1693-2Diphenoxylate Hydrochloride and Atropine Sulfate30 in 1 BOTTLETABLET304
71335-1693-3Diphenoxylate Hydrochloride and Atropine Sulfate15 in 1 BOTTLETABLET154
71335-1693-4Diphenoxylate Hydrochloride and Atropine Sulfate10 in 1 BOTTLETABLET104
71335-1693-5Diphenoxylate Hydrochloride and Atropine Sulfate40 in 1 BOTTLETABLET404
71335-1693-6Diphenoxylate Hydrochloride and Atropine Sulfate60 in 1 BOTTLETABLET604
71335-1693-7Diphenoxylate Hydrochloride and Atropine Sulfate90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1693DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 7 package rows20240824_b3f58de9-1cc8-4bc5-842f-010cc48d3582.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSNb3f58de9-1cc8-4bc5-842f-010cc48d35824
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDb3f58de9-1cc8-4bc5-842f-010cc48d35824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1693-17133516930120 TABLET in 1 BOTTLE (71335-1693-1) 20 tablet2020-10-130000-00-00NoNoCurrent
71335-1693-27133516930230 TABLET in 1 BOTTLE (71335-1693-2) 30 tablet2020-12-100000-00-00NoNoCurrent
71335-1693-37133516930315 TABLET in 1 BOTTLE (71335-1693-3) 15 tablet2021-12-290000-00-00NoNoCurrent
71335-1693-47133516930410 TABLET in 1 BOTTLE (71335-1693-4) 10 tablet2020-09-030000-00-00NoNoCurrent
71335-1693-57133516930540 TABLET in 1 BOTTLE (71335-1693-5) 40 tablet2021-12-290000-00-00NoNoCurrent
71335-1693-67133516930660 TABLET in 1 BOTTLE (71335-1693-6) 60 tablet2021-12-290000-00-00NoNoCurrent
71335-1693-77133516930790 TABLET in 1 BOTTLE (71335-1693-7) 90 tablet2021-12-290000-00-00NoNoCurrent