FDA.reportPublic FDA data

Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
43353-083
11-digit product format
433530083
Labeler code
43353
Product ID
43353-083_a923a016-80b4-4a98-9494-ada455890843
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA012462
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-02-27
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
43353-083-30Diphenoxylate Hydrochloride and Atropine Sulfate30 in 1 BOTTLETABLET301
43353-083-53Diphenoxylate Hydrochloride and Atropine Sulfate60 in 1 BOTTLETABLET601
43353-083-60Diphenoxylate Hydrochloride and Atropine Sulfate90 in 1 BOTTLETABLET901
43353-083-70Diphenoxylate Hydrochloride and Atropine Sulfate120 in 1 BOTTLETABLET1201
43353-083-80Diphenoxylate Hydrochloride and Atropine Sulfate180 in 1 BOTTLETABLET1801
43353-083-90Diphenoxylate Hydrochloride and Atropine Sulfate240 in 1 BOTTLETABLET2401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-083-30EA - Each43353-083280a5fc0-b440-4ceb-8748-1df338a35d4b12016-07-19
43353-083-53EA - Each43353-083529c99d1-d6fb-411f-831e-dc15f924d73312016-07-19
43353-083-60EA - Each43353-0839fe85d0e-ae34-4dc9-b63a-a38b4ef448ce12016-07-19
43353-083-70EA - Each43353-08394a38580-4561-472a-a95b-a76dffe7ac4012016-07-19
43353-083-80EA - Each43353-0832374c5e3-624f-483f-a1d3-e102d4de1e7a12016-07-19
43353-083-90EA - Each43353-083b9e6fbe3-1334-4b09-a241-2b749c9bb09c12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-083DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 6 package rows20160706_59934cee-4e1f-4958-9e97-6de53b39daf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN59934cee-4e1f-4958-9e97-6de53b39daf31
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD59934cee-4e1f-4958-9e97-6de53b39daf31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-083-304335300833030 TABLET in 1 BOTTLE (43353-083-30) 30 tablet2015-07-130000-00-00NoNoCurrent
43353-083-534335300835360 TABLET in 1 BOTTLE (43353-083-53) 60 tablet2015-07-140000-00-00NoNoCurrent
43353-083-604335300836090 TABLET in 1 BOTTLE (43353-083-60) 90 tablet2015-07-130000-00-00NoNoCurrent
43353-083-7043353008370120 TABLET in 1 BOTTLE (43353-083-70) 120 tablet2015-07-130000-00-00NoNoCurrent
43353-083-8043353008380180 TABLET in 1 BOTTLE (43353-083-80) 180 tablet2015-08-150000-00-00NoNoCurrent
43353-083-9043353008390240 TABLET in 1 BOTTLE (43353-083-90) 240 tablet2015-07-270000-00-00NoNoCurrent