FDA.reportPublic FDA data

Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
69315-910
11-digit product format
693150910
Labeler code
69315
Product ID
69315-910_af054a1c-a0a1-4097-8170-3e7b070ad830
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Leading Pharma, LLC
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
69315-910-01Diphenoxylate Hydrochloride and Atropine Sulfate100 in 1 BOTTLETABLET1009
69315-910-09Diphenoxylate Hydrochloride and Atropine Sulfate90 in 1 BOTTLETABLET909
69315-910-10Diphenoxylate Hydrochloride and Atropine Sulfate1000 in 1 BOTTLETABLET10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-910DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [LEADING PHARMA, LLC]9Current NDC, Legacy NDC, 3 package rows20230217_1c188bc9-7c21-4717-94a0-cdfb581fb776.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN700aad61-fa8c-4ded-87b8-da966093075a11
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD700aad61-fa8c-4ded-87b8-da966093075a11
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN1c188bc9-7c21-4717-94a0-cdfb581fb7769
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD1c188bc9-7c21-4717-94a0-cdfb581fb7769
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN46d5b27b-a710-4767-b308-4f673ddb354c6
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD46d5b27b-a710-4767-b308-4f673ddb354c6
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSNd9a36478-4788-4107-e053-2a95a90ad6da5
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN1be4dd7d-766c-4b3c-8b86-4f219ab447265
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDd9a36478-4788-4107-e053-2a95a90ad6da5
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD1be4dd7d-766c-4b3c-8b86-4f219ab447265
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN3d0e2877-7a74-433f-8a31-e3e54aa9dc9f4
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 TabletSCD3d0e2877-7a74-433f-8a31-e3e54aa9dc9f4
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDb3f58de9-1cc8-4bc5-842f-010cc48d35824
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
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSNb8a2a78a-67ae-50a5-e053-2a95a90ad9a72
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSNf4c35a82-5927-5bc2-e053-2a95a90aea4d2
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN593f2d01-5d24-450e-a6cf-204b7420f9712
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN14bf7191-580f-76dc-e063-6294a90aed2a2
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD593f2d01-5d24-450e-a6cf-204b7420f9712
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDb8a2a78a-67ae-50a5-e053-2a95a90ad9a72
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDf4c35a82-5927-5bc2-e053-2a95a90aea4d2
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD14bf7191-580f-76dc-e063-6294a90aed2a2
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN23791c11-028a-41d3-9894-c75c6effa0f31
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD23791c11-028a-41d3-9894-c75c6effa0f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-910-0169315091001100 TABLET in 1 BOTTLE (69315-910-01) 100 tablet2020-03-150000-00-00NoNoCurrent
69315-910-096931509100990 TABLET in 1 BOTTLE (69315-910-09) 90 tablet2020-03-150000-00-00NoNoCurrent
69315-910-10693150910101000 TABLET in 1 BOTTLE (69315-910-10) 1000 tablet2020-03-150000-00-00NoNoCurrent