FDA.reportPublic FDA data

NDC 68071-4063-01 - Diphenoxylate Hydrochloride and Atropine Sulfate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68071-4063
Requested NDC
68071-4063-01
Package NDCs from labels
68071-4063-1, 68071-4063-5, 68071-4063-2, 68071-4063-3, 68071-4063-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx onlyNuCare Pharmaceuticals,Inc.2024-07-18HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-4063-12023-05-02Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-22023-05-02Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-32023-05-02Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-52023-05-02Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-12023-01-30Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-22023-01-30Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-32023-01-30Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-52023-01-30Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-12021-02-12Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-22021-02-12Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-32021-02-12Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-52021-02-12Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-12021-01-29Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-22021-01-29Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-32021-01-29Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-52021-01-29Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4063-1Diphenoxylate Hydrochloride and Atropine Sulfate10 in 1 BOTTLETABLET106
68071-4063-2Diphenoxylate Hydrochloride and Atropine Sulfate20 in 1 BOTTLETABLET206
68071-4063-3Diphenoxylate Hydrochloride and Atropine Sulfate30 in 1 BOTTLETABLET306
68071-4063-5Diphenoxylate Hydrochloride and Atropine Sulfate15 in 1 BOTTLETABLET156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4063DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 4 package rows20240720_575c38b4-7ec0-6d25-e053-2a91aa0a80fc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
AtropineATROPINE SULFATERedpharm Drug46e98d0b-3a04-7feb-e063-6394a90ac75e2025-12-27Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATERedpharm Drug301ea0f4-a1dc-ad4f-e063-6294a90acc1c2025-12-23Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATE INJECTIONMedefil, Inc.fbfdf718-befe-ad22-e053-6294a90a37152025-12-23Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEANI Pharmaceuticals, Inc.73dc5f91-d562-44c5-a556-66c96ed1dd822025-12-22Warnings, Adverse reactionsExact identifier
application number: ANDA086727
ndc (product): 62559-490
rxcui: 1190572
spl id: 540ac802-a419-42f7-8f7f-d770ea165243
spl set id: 73dc5f91-d562-44c5-a556-66c96ed1dd82
unii: W24OD7YW48
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEProPharma Distribution38404931-980b-0019-e063-6394a90a933f2025-12-18Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEProPharma Distribution3d5c747f-3bf7-2597-e063-6394a90a828c2025-12-18Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
GB-ToneAMMI VIS, ATROPINUM SULPHURICUM, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, ECHINACEA, FEL TAURI, HEPAR SUIS, HYDRASTIS, LEPTANDRA, MAG PHOS, NAT PHOS, PODOPH PELT, TARAXACUMEnergetix Corporation1d857ae7-ad24-4f3b-8c33-f52851fa1ce62025-12-17WarningsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEUnichem Pharmaceuticals (USA), Inc.5117f26c-488f-4ba6-b115-22baf12557f32025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Diphenoxylate hydrochloride and atropine sulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEChartwell RX, LLC240b537e-ff9b-45e3-9398-584372bd707a2025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
AtropineATROPINE SULFATEAmneal Pharmaceuticals NY LLCf8718be5-8fa4-4c36-a4fd-fac7c3953f5a2025-12-04Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
atropine sulfateATROPINE SULFATEAmneal Pharmaceuticals LLC80a31286-a741-4440-b200-290c08925d062025-12-01Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATENorthStar RxLLCf750135c-e6bf-4aa7-a343-87b1204df94f2025-11-12Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
MotofenDIFENOXIN AND ATROPINE SULFATESebela Pharmaceuticals Inc.4cd3f029-a5e3-5812-e054-00144ff8d46c2025-11-08Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATE MONOHYDRATEMedical Purchasing Solutions, LLC423fc064-57cb-8308-e063-6394a90a26172025-10-28Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHenry Schein, Incb753894e-81f8-4e81-b07a-c338311ded5b2025-10-27Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHenry Schein, Inc.6acb3f07-9e32-4ad0-8336-e2f33d55b1272025-10-27Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
Atropine SulfateATROPINE SULFATELifestar Pharma LLCb5f78b2a-56d1-4400-9d2f-b033cc13d26e2025-10-13Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.