FDA.reportPublic FDA data

Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
62559-490
11-digit product format
625590490
Labeler code
62559
Product ID
62559-490_540ac802-a419-42f7-8f7f-d770ea165243
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA086727
Marketing category
ANDA
Marketing start
2017-07-07
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
62559-490-01Diphenoxylate Hydrochloride and Atropine Sulfate100 in 1 BOTTLETABLET1005
62559-490-10Diphenoxylate Hydrochloride and Atropine Sulfate1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-490-01EA - Each62559-49066895a04-ebdf-4d93-b2fb-04a3a49eb85112017-07-07
62559-490-10EA - Each62559-4906711453d-44ff-4f22-b59c-b95bae4c7c8712017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-490DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [ANI PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20191017_73dc5f91-d562-44c5-a556-66c96ed1dd82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN64be1529-f290-422c-a076-32c0e1ced1a1103
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD64be1529-f290-422c-a076-32c0e1ced1a1103
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSNc69408c2-ccb6-40b1-ae48-e033831c29aa100
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDc69408c2-ccb6-40b1-ae48-e033831c29aa100
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSNbd08ed90-dd26-4629-83c0-0f75af6ebb958
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDbd08ed90-dd26-4629-83c0-0f75af6ebb958
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN2a6786a1-bf8c-4f19-98c5-8119df787a216
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN575c38b4-7ec0-6d25-e053-2a91aa0a80fc6
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD2a6786a1-bf8c-4f19-98c5-8119df787a216
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD575c38b4-7ec0-6d25-e053-2a91aa0a80fc6
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN73dc5f91-d562-44c5-a556-66c96ed1dd825
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD73dc5f91-d562-44c5-a556-66c96ed1dd825
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSNc832ef16-a06e-4e47-9df3-ab33bdfa6e564
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDc832ef16-a06e-4e47-9df3-ab33bdfa6e564
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN6856dfad-9c6e-5bd0-e053-2a91aa0a68f01
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN435e5e75-5a4c-4806-8d9e-d4be3fef92291
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD6856dfad-9c6e-5bd0-e053-2a91aa0a68f01
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD435e5e75-5a4c-4806-8d9e-d4be3fef92291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-490-0162559049001100 TABLET in 1 BOTTLE (62559-490-01) 100 tablet2017-07-070000-00-00NoNoCurrent
62559-490-10625590490101000 TABLET in 1 BOTTLE (62559-490-10) 1000 tablet2017-07-070000-00-00NoNoCurrent