FDA.reportPublic FDA data

Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
0054-3194
11-digit product format
000543194
Labeler code
0054
Product ID
0054-3194_92ce86bc-7f23-43ec-9374-a51bacef9461
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA087708
Marketing category
ANDA
Marketing start
1982-05-03
Substance
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Active strength
.025; 2.5 mg/5mL; mg/5mL
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
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5, W24OD7YW48
Rxcui1190568

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
0054-3194-46Diphenoxylate Hydrochloride and Atropine Sulfate60 mL in 1 BOTTLESOLUTION608
0054-3194-46Diphenoxylate Hydrochloride and Atropine Sulfate1 in 1 CARTONSOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3194-46ML - Milliliter0054-31947a17f727-3f97-4c86-8c29-406cdc172fe612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
MALTOLINACTIVE INGREDIENT3A9RD92BS4DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
SORBITOLINACTIVE INGREDIENT506T60A25RDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-3194DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20230502_88ed4ccf-9e35-4142-a5eb-d2b5edd36956.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral SolutionPSN88ed4ccf-9e35-4142-a5eb-d2b5edd369568
1190568atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral SolutionSCD88ed4ccf-9e35-4142-a5eb-d2b5edd369568
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral SolutionSY88ed4ccf-9e35-4142-a5eb-d2b5edd369568
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral SolutionPSNb0c91667-ab6f-481d-a592-62da8a52abf72
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral SolutionPSNcb933606-151e-4fa4-bebe-b11c1ec411002
1190568atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral SolutionSCDb0c91667-ab6f-481d-a592-62da8a52abf72
1190568atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral SolutionSCDcb933606-151e-4fa4-bebe-b11c1ec411002
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral SolutionSYb0c91667-ab6f-481d-a592-62da8a52abf72
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral SolutionSYcb933606-151e-4fa4-bebe-b11c1ec411002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-3194-46000543194461 BOTTLE in 1 CARTON (0054-3194-46) / 60 mL in 1 BOTTLE1 bottle1982-05-030000-00-00NoNoCurrent