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 5 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anise PyriteANISE PYRITEUriel Pharmacy Inc.a03cdeb0-8347-40cc-8d17-5510d99575c72025-01-22WarningsExact identifier
unii: C151H8M554
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDirect Rxd9a36478-4788-4107-e053-2a95a90ad6da2025-01-21Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
A-5SUCROSEDNA Labs, Inc.8e63f697-26c1-4518-acd3-5ea72cfa27f72025-01-09WarningsExact identifier
unii: C151H8M554
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLC3f931937-7bc0-416b-e063-6294a90a28b52025-01-03Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.adfee6ce-05b0-4955-bf5f-9612b8db4c782024-12-26WarningsExact identifier
unii: C151H8M554
Atropine SulfateATROPINE SULFATE MONOHYDRATESomerset Therapeutics, LLC84ba1689-3030-48d5-9cce-70b5a24a40332024-12-10Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEAdvanz Pharma (US) Corp.c93cccdc-2f92-4cb3-9d14-06acdd51d94c2024-12-05Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEAdvanz Pharma (US) Corp.4dba30db-7979-455f-a225-24f0a04d744e2024-12-05Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEAccord Healthcare Inc.f3cb74e9-b4ac-4efe-bd8e-8a71970ee7c72024-11-20Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEA-S Medication Solutions1be4dd7d-766c-4b3c-8b86-4f219ab447262024-11-13Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
FocusADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUMDeseret Biologicals, Inc.e014e6b6-a07a-4170-b9af-f477da71597d2024-11-13WarningsExact identifier
unii: C151H8M554
LactistatARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, GRAPHITES, HYDROFLUORICUM ACIDUM, LACHESIS MUTUS, LACTICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SACCHARUM OFFICINALEEnergique, Inc.8dcc4a3a-9f21-4a77-ae42-b2c8283a076a2024-10-28WarningsExact identifier
unii: C151H8M554
Grain and Seed AntigensBAMBOO, BARLEY, CORN, COTTON SEED, FLAX SEED (LINUM USITATISSIMUM), MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SAFFLOWER, SESAME, SORGHUM, SOY BEAN, SUGARCANE, SUNFLOWER (HELIANTHUS ANNUUS), WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUREnergique, Inc.a028eaea-76ef-45db-80e1-d7b4a0655d5e2024-10-25WarningsExact identifier
unii: C151H8M554
Atropine SulfateATROPINE SULFATEFresenius Kabi USA, LLC310c8a74-ea24-4357-8099-81e394b1634e2024-10-11Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
unii: C151H8M554
PMS ReliefAGNUS CASTUS, AURUM SULPHURATUM, CANDIDA ALBICANS, CIMICIFUGA RACEMOSA, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, FOLLICULINUM, HYPOTHALAMUS SUIS, KALI CARBONICUM, LAC CANINUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), SACCHARUM OFFICINALE, STANNUM METALLICUM, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Deseret Biologicals, Inc.f03d8463-0a6d-4577-8fba-9cba246d3d452024-09-23WarningsExact identifier
unii: C151H8M554
STOMAPLEXCARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA (CASSIA ANGUSTIFOLIA), STOMACH (BOVINE), ARSENICUM ALBUM, ATROPINUM SULPHURICUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUSBioActive Nutritional, Inc.e1b69e9b-ab47-49f4-bd91-89c935533d672024-09-11WarningsExact identifier
unii: 03J5ZE7KA5
FocusGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, IODIUM, PHOSPHORUS, SARCOLACTICUM ACID, SACCHARUM OFFICINALE, ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, SILICEA, ADRENALINUM, AMBRA GRISEA, CARBONEUM SULPHURATUM, TARENTULA HISPANA, AETHUSA CYNAPIUM, BARYTA CARBONICA, HELLEBORUS NIGER, VERATRUM ALBUM, CANDIDA ALBICANS, HYOSCYAMUS NIGERDeseret Biologicals, Inc.e77857b8-be67-4041-8c8d-9772f17c6d062024-09-11WarningsExact identifier
unii: C151H8M554
PMS ReliefAGNUS CASTUS, CIMICIFUGA RACEMOSA, KALI CARBONICUM, LYCOPODIUM CLAVATUM, SACCHARUM OFFICINALE, THYROIDINUM (BOVINE), HYPOTHALAMUS SUIS, ARISTOLOCHIA CLEMATITIS, FOLLICULINUM, AURUM SULPHURATUM, CANDIDA ALBICANS, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, LAC CANINUM, LACHESIS MUTUS, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), STANNUM METALLICUMDeseret Biologicals, Inc.ca073beb-330d-406c-9bf5-196a89f3ab582024-09-11WarningsExact identifier
unii: C151H8M554
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEBryant Ranch Prepackb3f58de9-1cc8-4bc5-842f-010cc48d35822024-08-23Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

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